February 19, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals
Hazard: CGMP deviations: Product bottle may be absent of desiccant.
February 19, 2020DrugsFDA
Pfizer Inc. recalls Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intrav
Hazard: Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
February 19, 2020DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited,
Hazard: cGMP Deviations
February 19, 2020DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Is
Hazard: Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
February 12, 2020DrugsFDA
Macleods Pharma Usa Inc recalls Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods
Hazard: Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
February 12, 2020DrugsFDA
Graviti Pharmaceuticals Private Limited recalls Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08
Hazard: Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
February 12, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauder
Hazard: GMP Deviations: Product bottle may be absent of desiccant.
February 12, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauder
Hazard: GMP Deviations: Product bottle may be absent of desiccant.
February 12, 2020DrugsFDA
UNICHEM PHARMACEUTICALS USA INC recalls Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilern
Hazard: Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
February 12, 2020DrugsFDA
Ascend Laboratories LLC recalls Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 4
Hazard: cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
February 12, 2020DrugsFDA
Ascend Laboratories LLC recalls Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Labor
Hazard: Failed Dissolution Specifications: low out of specification results for dissolution testing.
February 12, 2020DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-
Hazard: CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
February 12, 2020DrugsFDA
Spectrum Laboratory Products recalls Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
February 5, 2020DrugsFDA
Pharmaceutical Associates Inc recalls Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceut
Hazard: Subpotent: Out of specification for assay at the 12-month time point.
February 5, 2020DrugsFDA
Macleods Pharma Usa Inc recalls Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plain
Hazard: Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
February 5, 2020DrugsFDA
Shandex Personal Care Manufacturing Inc. recalls Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co.,
Hazard: Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
February 5, 2020DrugsFDA
McGuff Compounding Pharmacy Services, Inc. recalls Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Phar
Hazard: Presence of Particulate Matter: Particulates observed in vials release for dispensing.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Testosterone Topical Cream 4%
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Tadalafil 6 mg Capsule
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Tadalafil 20 mg Troche
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls T3/T4 SR 9 mcg/38 mcg capsule
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Squaric Acid 0.1% Topical Solution (Clinic) 30 mL
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Sildenafil 80 mg capsules
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Sildenafil 200 mg Troche (Clinic)
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Progesterone E4M SR 100 mg capsules
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Progesterone 50 mg capsules
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Progesterone 200 mg Troche
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Naltrexone 4.5 mg capsule
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Magic Bullet Supplement
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Liothyronine (T3) 92.5 MCG
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.