April 11, 2018DrugsFDA
Mayne Pharma Inc recalls Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-29
Hazard: Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
April 4, 2018DrugsFDA
Jimmy Weber recalls Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/202
Hazard: Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
April 4, 2018DrugsFDA
Apollo Care recalls Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columb
Hazard: Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
April 4, 2018DrugsFDA
Apollo Care recalls Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia,
Hazard: Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
April 4, 2018DrugsFDA
Akorn, Inc. recalls 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Glucon
Hazard: Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
April 4, 2018DrugsFDA
Akorn, Inc. recalls 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Glucon
Hazard: Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
April 4, 2018DrugsFDA
Akorn, Inc. recalls Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups
Hazard: Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
April 4, 2018DrugsFDA
Amneal Pharmaceuticals recalls Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ
Hazard: Presence of particulate matter
April 4, 2018DrugsFDA
Bracco Diagnostics Inc. recalls E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM
Hazard: Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
April 4, 2018DrugsFDA
Paddock Laboratories, LLC. recalls Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for
Hazard: Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
April 4, 2018DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bar
Hazard: Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
April 4, 2018DrugsFDA
Renaissance Lakewood, LLC recalls Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for:
Hazard: Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
March 28, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC
Hazard: Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
March 28, 2018DrugsFDA
Akorn, Inc. recalls Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 3006
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
March 28, 2018DrugsFDA
Pine Pharmaceuticals, LLC recalls Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy
Hazard: Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
March 28, 2018DrugsFDA
Fresenius Medical Care Renal Therapies Group, LLC recalls DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2
Hazard: Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
March 21, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ
Hazard: Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
March 21, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscatawa
Hazard: Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
March 21, 2018DrugsFDA
Novel Laboratories, Inc. recalls Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Nov
Hazard: Failed Impurities/Degradation Specifications
March 21, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 0
Hazard: Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
March 21, 2018DrugsFDA
Pfizer Inc. recalls Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. H
Hazard: Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
March 21, 2018DrugsFDA
Pfizer Inc. recalls Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mf
Hazard: Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
March 21, 2018DrugsFDA
American Pharmaceutical Ingredients LLC recalls Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 5859
Hazard: Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
March 21, 2018DrugsFDA
American Pharmaceutical Ingredients LLC recalls Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
Hazard: Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
March 21, 2018DrugsFDA
Alva-Amco Pharmacal Companies., Inc. recalls Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by
Hazard: Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
March 21, 2018DrugsFDA
Sagent Pharmaceuticals Inc recalls methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Ph
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
March 21, 2018DrugsFDA
Sagent Pharmaceuticals Inc recalls methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Ph
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
March 21, 2018DrugsFDA
Sagent Pharmaceuticals Inc recalls methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pha
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
March 14, 2018DrugsFDA
Mckesson Packaging Services recalls RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 1
Hazard: Failed Stability Specifications
March 14, 2018DrugsFDA
SCA Pharmaceuticals, LLC. recalls labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 -
Hazard: Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018