Class I - Dangerous
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.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
Spectrum Laboratory Products
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01
Teva Pharmaceuticals USA
Class I - Dangerous
GMP Deviations: Product bottle may be absent of desiccant.
Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.
Graviti Pharmaceuticals Private Limited
Class I - Dangerous
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.
Class I - Dangerous
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class I - Dangerous
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01
Teva Pharmaceuticals USA
Class I - Dangerous
GMP Deviations: Product bottle may be absent of desiccant.
Class I - Dangerous
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Progesterone 200 mg Troche
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
Pharmaceutical Associates
Class I - Dangerous
Subpotent: Out of specification for assay at the 12-month time point.
Tadalafil 6 mg Capsule
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Naltrexone 4.5 mg capsule
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Sildenafil 80 mg capsules
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Progesterone E4M SR 100 mg capsules
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Testosterone Topical Cream 4%
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Finasteride/Biotin 1 mg/50 mcg
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Magic Bullet Supplement
MPRX, Inc.
Class I - Dangerous
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.