January 13, 2021DrugsFDA
Ascend Laboratories LLC recalls Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 20
Hazard: Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
January 13, 2021DrugsFDA
Merck Sharp & Dohme recalls Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & D
Hazard: Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
January 6, 2021DrugsFDA
Wishgarden Herbs, Incorporated recalls Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9
Hazard: Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
January 6, 2021DrugsFDA
Wishgarden Herbs, Incorporated recalls Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4
Hazard: Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
January 6, 2021DrugsFDA
Wishgarden Herbs, Incorporated recalls Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5
Hazard: Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
January 6, 2021DrugsFDA
Fresenius Kabi USA, LLC recalls Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresen
Hazard: Presence of Particulate Matter - found in reserve sample vials at the firm.
January 6, 2021DrugsFDA
CIPLA recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by
Hazard: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
January 6, 2021DrugsFDA
CIPLA recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by
Hazard: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
January 6, 2021DrugsFDA
CIPLA recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by
Hazard: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
January 6, 2021DrugsFDA
Strides Pharma Inc. recalls NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengalur
Hazard: Failed Moisture Limits
January 6, 2021DrugsFDA
Ascend Laboratories LLC recalls Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by
Hazard: Failed Impurity/Degradation Specifications
January 6, 2021DrugsFDA
Ascend Laboratories LLC recalls Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by
Hazard: Failed Impurity/Degradation Specifications
January 6, 2021DrugsFDA
Imprimis NJOF, LLC recalls Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 W
Hazard: Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
January 6, 2021DrugsFDA
US Compounding Inc recalls Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don
Hazard: Labelling: Missing label.
December 30, 2020DrugsFDA
Morton Grove Pharmaceuticals, Inc. recalls Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-
Hazard: Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
December 30, 2020DrugsFDA
Fresenius Kabi USA, LLC recalls Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dos
Hazard: Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
December 30, 2020DrugsFDA
SCA Pharmaceuticals, Inc. recalls Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoed
Hazard: Subpotent drug.
December 30, 2020DrugsFDA
Akebia Therapeutics dba Keryx Biopharmaceutials, Inc recalls Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHAR
Hazard: CGMP Deviations
December 23, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 0
Hazard: Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
December 23, 2020DrugsFDA
AVKARE Inc. recalls TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC
Hazard: Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
December 23, 2020DrugsFDA
AVKARE Inc. recalls Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
Hazard: Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
December 23, 2020DrugsFDA
CIPLA recalls Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa
Hazard: cGMP deviations: Vials may not be sealed correctly affecting sterility.
December 23, 2020DrugsFDA
Simex Logistics SA de CV recalls Lavar 70 Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC. 1130 A
Hazard: Subpotent drug
December 23, 2020DrugsFDA
Simex Logistics SA de CV recalls UVT World Gel Hand Sanitizer 70% Alcohol Content, 33.9 FL OZ (1LT), Distributed By UVT World Newport Beach, CA 92660 www
Hazard: Subpotent drug
December 23, 2020DrugsFDA
Simex Logistics SA de CV recalls Health & Hand Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC 11
Hazard: Subpotent drug
December 23, 2020DrugsFDA
Simex Logistics SA de CV recalls CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L), Distributed By Citru Gel Inc.
Hazard: Subpotent drug
December 23, 2020DrugsFDA
Simex Logistics SA de CV recalls +Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic, packaged in bottles of
Hazard: Subpotent drug
December 23, 2020DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro Pharmaceut
Hazard: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
December 23, 2020DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by T
Hazard: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
December 23, 2020DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Distributed by: Valu Merchandisers, CO . 500
Hazard: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.