Class I - Dangerous
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Presence of foreign substance: plastic-like substance.
Class I - Dangerous
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
Dr. Reddy's Laboratories
Class I - Dangerous
Sub-potent Drug; powder discoloration associated with decreased potency
Class I - Dangerous
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Out of specification for assay
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.
Dr. Reddy's Laboratories
Class I - Dangerous
Sub-potent Drug; powder discoloration associated with decreased potency
Class I - Dangerous
Discoloration: Dotted and yellow spots on tablets
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00
Rubicon Research Private Limited
Class I - Dangerous
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Class I - Dangerous
Discoloration: Dotted and yellow spots on tablets
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.
Breckenridge Pharmaceutical
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.
Breckenridge Pharmaceutical
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06
Acella Pharmaceuticals
Class I - Dangerous
Subpotent drug
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Out of specification for assay
Class I - Dangerous
Labeling: Wrong Barcode
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Amneal Pharmaceuticals of New York
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.