FDA Recalls in 2016
5,451 recalls found
December 2016
The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking.
Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
The firm, EKOS, sent an "URGENT FIELD SAFETY ACTION" letter dated August 22, 2016 to its customers. The letters were sent to customers informing them of the field safety action, how to identify the affected carts at their facility and instructing customers locate the cart, quarantine it and do not use the cart for any procedures. A representative from EKOS Corporation will be contacting customers in the near future to arrange a date and time when the cart at a facility can be inspected and any affected caster(s) replaced. As the cart is inspected, it will be tagged to easily identify it and confirm it has been inspected and repaired as necessary. Customers will be provided with a copy of the inspection/repair form for the cart they inspect. Please retain that form for records. If customers have any questions, please contact EKOS Customer Service at 1-888-400-3567 or your local EKOS representative.
Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01
Lack of Assurance of Sterility: Potential cracks in glass vials
2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818
Non Sterility; contaminated with Klebsiella pneumoniae
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
Failed Dissolution Specifications; 6 month time point
Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP
Lack of Sterility Assurance
GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15
Defective delivery system: detached needles on the syringe in the kit.
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950
Labeling: Label Mix Up- Incorrect back label applied to the product.
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80;
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
Non-Sterility; microbial contamination identified as Bacillus circulans
Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80;
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Non-Sterility: failed sterility test result.
Gourmet Chocolate Dipped Cookies Net Wt. 46 oz UPC 269969414994
Cookies may contain metal pieces.
Turkey, Bacon and Swiss on Macaroni Salad wrapped in clear film, 8 oz. Undeclared allergens - Wheat, Soy (oil, flour), Milk, Egg
Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.
2/1 GL JAR SYSCO IMP. SPRING MIX
Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "N34D SALT-FREE ROASTED SUNFLOWER SEEDS".
Sunflower seeds purchased from SunOpta that are potentially contaminated with Listeria.
PREMIUM SMOKED SALMON UPC 7 02772 00564 0 Packaged in a 5 lb case 20/4oz vacuum packaged per case. Cardboard type label is folded over and affixed to the top of the package. Sell by date is marked on the label by the consignee.
Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.
"***PREMIUM SMOKED SALMON***CRACKED PEPPER*** NET WT: 4OZ***Packaged 5 lbs case 20/4oz vacuum packages/case. Cardboard type label is folded over and affixed to the top of the package. Sell by date is marked on the label by the consignee. UPC 7 02772 00560 2.
Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.
Apple Orchard Crisp Apple Hard Cider Three packages sizes: ¿ Loose case = 24 12 oz bottles ¿ 12 pack = 12 12 oz bottles, shipped as 2 12 packs per case ¿ 4 6 pack = 6 12 oz bottles per pack, shipped as 4 6 packs per case
Due to concerns of re-fermentation, bottles may burst under increased pressure.
1 GL PAIL SYSCO FRUIT MIX - LS, UPC 47486540223
Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
1 GL CVF CANTALOUPE CHUNKS - LS, UPC 50758108449775;
Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
WILD CATCH PREMIUM SMOKED SALMON***NATURAL***NET WT: 4OZ*** UPC 7 02772 00559 6. Cardboard type label is folded over and affixed to the top of the package. Sell by date is marked on the label by the consignee.
Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.
Hot Sicilian- Ham, Pepperoni and Provolone Cheese wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy( oil flour), Milk
Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.
Raisin Bagel with Cream Cheese wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy (oil), and Milk
Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.
1 GL PAIL SYSCO CANTALOUPE CHUNKS - LS, UPC 7486548718
Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
1 GL PAIL SYSCO IMP. CANTALOUPE/GRAPE JUICE, UPC 7486562450
Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
Preferred Meals, Cook and Serve, Cavatappi Pasta with Mascarpone Tomato Cream Sauce; 54 9.25 OZ units (NET WEIGHT 31.22 LBS) KEEP FROZEN INSTITUTIONAL USE ONLY
Possible contamination of product with Listeria monocytogenes.
CROISSANT 6 PK
Product contains undeclared eggs.
Coconut Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz.
Coconut Fudge is recalled due to undeclared blue #1.
Egg Salad on Wheat wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy (oil) and eggs
Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.
24CT Take&Bake Oatmeal Rasin Cookies Net Wt. 24oz UPC 20873004194
Cookies may contain metal pieces.
4 GL PAIL FRUIT MIX-SMALL CUT, UPC 4294710455
Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
Hot Sausage on Club wrapped in clear film, 6 oz. Undeclared allergens - Wheat, Soy (oil)
Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.
Ben & Jerrys Brownie Batter Core Ice Cream One Pint (473 mL). Case UPC- 10076840529879 Consumer UPC - 7684052987 Paper carton 8 units per shrink-wrapped case Frozen
Certain pints of Ben & Jerrys Brownie Batter Core Ice Cream may contain soft plastic pieces.
Plain Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12,16, and 24 oz.
Plain Fudge is recalled due to undeclared blue #1.