FDA Recalls in 2019
4,753 recalls found
January 2019
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478.
Subpotent
Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC: 47335-932-40 [vial] 47335-932-44 [carton]
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07
GMP Deviations: A silicone particulate was noted in Ozurdex.
Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton]
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Artis Q and Q.Zen fluoroscopic x-ray system
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
A Customer Safety Advisory Notice (CSAN) was mailed to affected customers on 02/27/2017 to inform them of the issue. The notice provided information on what actions to take should the foot switch fail to function, the risks involved and what corrective actions they are taking to fix the issue.
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
Stryker Spine issued an "Urgent Product Removal Notifications /Customer Response Forms dated September 11, 2015. to all affected customers via Fed Ex priority overnight. The notification instructed customers on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Customers were asked to examine their inventory and related hospital location inventories; and reconcile any UniVise Inserters with Catalog numbers and Lot numbers (referenced in the notification). Customers were asked to fax a copy of the Customer Response Form to Regulatory Compliance (at 855-632-9049) or email it to Spine-RegulatoryActions@Stryker.com within 5 days of receipt of the notification. For further questions please call (201) 760-8346.
Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist
Potentially lead to anchor breakage during insertion,
On November 19, 2018 Arthrex sent communications to their customers indicating the following about their recall: REQUIRED ACTION BY RECIPIENT 1. Immediately discontinue use, sale, and distribution of the affected product. 2. Please contact Arthrex Product Surveillance at 866-267-9138 or complai nts@arthrex.com (for direct Customers); contact FLS@arthrex.com (for Agencies) as soon as possible to arrange for return of the affected product. Our Product Surveillance Specialists can provide assistance regarding alternative solutions and are available to answer questions regarding credit for affected devices in your possession. 3. If you are an Arthrex agency, you do not need to notify any customers as Arthrex will be notifying customers directly. 4. If you are an Arthrex customer, you do not need to notify any patients of this product recall. 5. If you have any questions about this product recall, please contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com.
Elekta Unity
In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.
The firm notified their consignees about the issue on 01/04/2019 and will install additional fixation.
Discover VH/Millennium VG Nuclear Medicine Imaging System
A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan.
The firm initiated the medical device correction by letter on 10/0/2017. The letter instructed the consignee to ensure the collimator locking handles are in the locked position at all times. GE Healthcare will inspect and if necessary correct all affected products.
Epinephrine liquid 1:1000, RX, glass vial
Lack of sterility assurance.
Cyclosporin liquid 1%, Rx, plastic dropper bottle
Lack of sterility assurance.
Cyclosporin liquid 0.5%, Rx, plastic dropper bottle
Lack of sterility assurance.
Cyclosporin liquid 0.05%, Rx, plastic dropper bottle
Lack of sterility assurance.
Vitamin B12 liquid 1000mcg/ml, RX, glass vial
Lack of sterility assurance.
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11.
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Cyclosporin liquid 0.2%, Rx, plastic dropper bottle
Lack of sterility assurance.
Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye
Lack of sterility assurance.
Testosteron Cypionate liquid 200mg/ml, RX, glass vial
Lack of sterility assurance.
HCG liquid, 1000u/ml, RX, glass vial, various
Lack of sterility assurance.
Lidocaine gel 1%, RX, plastic dropper
Lack of sterility assurance.
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
Lack of sterility assurance.
Glutathione liquid, 200mg/ml, Rx
Lack of sterility assurance.
Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial
Lack of sterility assurance.
Lidocaine gel 2%, RX, plastic dropper
Lack of sterility assurance.
Methocarbamol liquid 100mg/ml, RX, glass vial
Lack of sterility assurance.
Glutathione liquid, 100mg/ml
Lack of sterility assurance.
Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments
Lack of sterility assurance.
Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, w
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
On November 28, 2018, Boston Scientific sent Urgent Medical Device Removal - Immediate Action Required letters to their Japanese consignees requesting them to check and segregate any of the recalled product. The letter also asked the consignees to conduct sub-recalls, if necessary, and to return The Reply Verification Tracking Form.
VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serologi
The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.
On November 1, 2018, a customer letter was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail to all customers who could process the affected products to inform them of the potential interference of biotin at levels lower than stated in the IFUs and that Ortho is in the process of revising the IFUs for the affected products. Ortho recommended customers follow normal laboratory procedures for troubleshooting of samples containing other assay interferences and it was acceptable to continue using the affected products. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
Failed Dissolution Specifications
1) PICA-BOLA 50 pieces Cont. Net 1 kg Net Wet. 2 lb 3.2 oz., packaged in a clear plastic ja, 6 jars per case and 2) PICA-BOLA 40 pieces Net Wet. 1 lb. 12.2 oz. packaged in a plastic bag, 11 bags per case and 3) PICA-BOLA 100 pieces Net Wt. 100-0.70 oz (4 lb 6.5 oz.) packaged in a clear plastic ja, 6 jars per case
Undeclared soy in candy
Eat Smart Salad Shake Ups - Sweet Kale/Chou Frise Doux: 5.5 oz. (156 g); US UPC 7 09351-30240 4; Canadian UPC: 7 09351 30243 5. Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
El Super Leon Jabalina Xtreme 50 pieces Net Wt. 2 lb. (3.2 oz.) Cont. Net. 1 kg packaged in a clear plastic jar, 6 jars per case
Undeclared soy in candy
Sea Salt Caramels Tumbled In Milk Chocolate, Moonstruck brand. The product sold in an individual resealable plastic bag, net wt. 4 oz. The product is number is 312235 and the UPC code is 7 11175 12235 9. The product also sold in cardboard box of 8/4 oz. bags. The box has the SKU number 312235 and the UPC code 10711175122356.
The Sea Salt Caramels Tumbled In Milk Chocolate is recalled due to a potential to be contaminated with hazelnuts and the finished label does not declare hazelnuts.
Frozen Unbreaded French onion / Swiss and Onion CC. Sample Number 17-0160.01. Keep Frozen at 0-degrees or below zero. "Food for Research or Evaluation Use". Sargento Technical Center, Elkhart Lake, WI 53020
Sargento is recalling Frozen Unbreaded French Onion CC, Frozen Unbreaded Egg 3 cheese and caramelized Onion and Frozen Unbreaded Egg, Gouda, caramelized onion due to potential Listeria monocytogenes or Salmonella contamination.
Eat Smart Salad Shake Ups - Asian Sesame/Sesame Asiatique; 5.5 oz. (156 g); UPC 7 09351-30241 1, 7 09351 30244 2 Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
FLECHAZO 36 pieces Net Wt. 1 lb. 12.5 oz. packaged in a clear plastic jar, 6 jars per case
Undeclared soy in candy
Eat Smart Salad Shake Ups - Raspberry Acai/Framboises ET: 5.5 oz. (156 g); US UPC 7 09351-30178 0; Canadian UPC: 7 09351 30196 4. Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
Eat Smart Salad Shake Ups - Avocado Ranch/Ranch et Avocats: 5.5 oz. (156 g); US UPC: 7 09351-30177 3; Canadian UPC: 7 09351 30195 7; Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
Frozen Unbreaded Egg, 3 Cheese and caramelized onion. Sample Number 18-0115.01. Keep Frozen at 0-degrees or below zero. "Food for Research or Evaluation Use". Sargento Technical Center, Elkhart Lake, WI 53020
Sargento is recalling Frozen Unbreaded French Onion CC, Frozen Unbreaded Egg 3 cheese and caramelized Onion and Frozen Unbreaded Egg, Gouda, caramelized onion due to potential Listeria monocytogenes or Salmonella contamination.
Tamy Pop 18 pieces Net Wt. 1 lb. 15.7 oz. packaged in a clear plastic jar, 6 jars per case
Undeclared soy in candy
Eat Smart Salad Shake Ups - Tropical Lime/Lime Tropicale 5.5 oz. (156 g); US UPC 7 09351-30179 7; 7 09351 30197 1 Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
Frozen Unbreaded Egg, Gouda, caramelized onion. Sample Number 18-0116.01. Keep Frozen at 0-degrees or below zero. "Food for Research or Evaluation Use". Sargento Technical Center, Elkhart Lake, WI 53020
Sargento is recalling Frozen Unbreaded French Onion CC, Frozen Unbreaded Egg 3 cheese and caramelized Onion and Frozen Unbreaded Egg, Gouda, caramelized onion due to potential Listeria monocytogenes or Salmonella contamination.