April 25, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 6
Hazard: Defective Delivery System: Out of specification for adhesive transfer.
April 18, 2018DrugsFDA
InvaGen Pharmaceuticals, Inc. recalls Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla
Hazard: Failed impurities/degradation specifications: Failure to water content and impurity
April 18, 2018DrugsFDA
Lake Erie Medical & Surgical Supply Inc recalls Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date
April 18, 2018DrugsFDA
United Pacific Co Ltd recalls Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
Hazard: CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
April 18, 2018DrugsFDA
Elroselabs Inc. recalls Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured for Elrose Labs, Inc., Sanford,
Hazard: cGMP Deviations
April 18, 2018DrugsFDA
Elroselabs Inc. recalls Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc.
Hazard: cGMP Deviations
April 18, 2018DrugsFDA
Elroselabs Inc. recalls Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs, Sanford Fl 32771 USA --- NDC 702
Hazard: cGMP Deviations
April 11, 2018DrugsFDA
InvaGen Pharmaceuticals, Inc. recalls buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-
Hazard: Failed Dissolution Specifications; during stability testing
April 11, 2018DrugsFDA
InvaGen Pharmaceuticals, Inc. recalls buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc.
Hazard: Failed Dissolution Specifications; during stability testing
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.