Class I - Dangerous
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA.
Golden State Medical Supply
Class I - Dangerous
CGMP Deviations
Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
Golden State Medical Supply
Class I - Dangerous
CGMP Deviations
Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
Golden State Medical Supply
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
Golden State Medical Supply
Class I - Dangerous
CGMP Deviations
Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Wedgewood Village Pharmacy
Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class I - Dangerous
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Defective Container
Class I - Dangerous
Defective container: defect prevents product from dispensing as intended.
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Class I - Dangerous
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Class I - Dangerous
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.