2021 Product Recalls

4,623 recalls issued in 2021.

4,623
Total Recalls
63
USDA
219
CPSC
1,016
FDA Drug
USDA 63 CPSC 219 FDA Drug 1,016 FDA Device 1,052 NHTSA 1,093 FDA Food 1,180

Showing 4601–4620 of 4,623 recalls

FDA Class III

Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05

Labelling: Missing label.
FDA Class II

Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979

Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
FDA Class II

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
FDA Class II

Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-528-34

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
CPSC

Massage Guns Recalled for Fire Hazard

The lithium-ion battery system can overheat, posing a fire hazard.

Consumers should immediately stop using the recalled massage guns and contact Massimo for a full refund.
CPSC

Ozone 500® Density Bicycles Recalled for Fall Hazard

The locking hardware on the front wheel can become loose resulting in front wheel instability, posing fall and injury hazards.

Consumers should immediately stop using the recalled bicycles and contact Academy Sports + Outdoors for a free repair or free replacement hardware.
CPSC

Rust-Oleum Professional Bright Galvanizing Compound Spr Recalled for Injury Hazard

The bottom of the pressurized container can detach unexpectedly, posing an injury hazard.

Consumers should immediately stop using the recalled aerosol paint and contact Rust-Oleum for a full refund. Rust-Oleum will give consumers information on how to safely dispose of the product.
FDA Class II

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02

Presence of Particulate Matter - found in reserve sample vials at the firm.
FDA Class I

Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5

Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
FDA Class II

Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68

Failed Impurity/Degradation Specifications
FDA Class III

NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816

Failed Moisture Limits
FDA Class II

Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88

Failed Impurity/Degradation Specifications
FDA Class I

Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9

Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
FDA Class II

Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
FDA Class I

Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4

Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
FDA Class I

Trader Joe's Lightly Salted Edamame: Fully Cooked Soybeans in Pod. Keep Frozen NET WT 16 oz. (1 lb.) 454 g UPC: 0051 0639 Ingredients: Edamame (soybeans), salt Heating: microwave (1200 watt); Microwave cook times may vary depending on oven wattage. Open and pour into a microwave safe dish; heat 3-4 minutes at 50% power and serve. Distributed by Trader Joe's, Monrovia, CA Product of Thailand

Firm routine testing resulted in a positive result for Listeria monocytogenes in one bag of frozen edamame.
FDA Class III

Darlington's Soft Baked Cookies, Sugar Free Net Wt. 0.75 oz (21 g), Darlington, Noblesville, IN

An internal quality review found that an ingredient contained a milk derivative, but milk was not declared on the label.
FDA

Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery Equipment; 2008K@home, Common Name: Hemodialysis Delivery System

The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part.

Starting October 7, 2019, the firm began implementing the improved Pressure Transducers into machine production. On January 29, 2020, the firm's Technical Services began contacting clinics via phone call on to set up appointments for transducer replacements for 2008T and 2008T Blue Star machines affected by the recall. Customers may also contact FMCRTG Technical Service at 800-227-2572.
FDA Class II

Multigrain Solene Figotte, prebaked frozen breads with seeds, Item 29497, Net Weight 8.8 Lbs (4 Kg), Lot: 1234567, UPC code (01)03604380294973(10)1234567(15)191121(91)0309000001,

Unapproved pesticide-ethylene oxide in sesame seeds from India used in the production of flour in bread ingredient Multigrain Solene Figotte (seeds bread) imported from France.
FDA

POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Dist

Complaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line pops off after the oxygen is turned on due to a clogged port.

The firm initiated recall by telephone beginning 7/11/2018 requesting return of the product.