FDA Drug Recalls in 2016

1,254 recalls found

December 2016

FDA

Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
FDA

USCG Boat Response Kit - Product Code 80-0353, North American Rescue

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
FDA

Aid Backpack Kit - Product Code 85-0917, North American Rescue

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
FDA

Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples).

Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
FDA

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmaceutica (Portugal,) SA Distributed by: Westward Eatowntown NJ 07724 USA, Shelf pack NDC 0143-9570-10, Unit dose NDC 0143-9570-01

Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
FDA

PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.

Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
FDA

Amphibious Trauma Kit - Product Code 85-0639, North American Rescue

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
FDA

Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
FDA

PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.

Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
FDA