Prescription Drug Recall: Enalapril Maleate Due to Manufacturing Deviations
Golden State Medical Supply Inc. is recalling 1,424 bottles of Enalapril Maleate 20 mg tablets due to Current Good Manufacturing Practice deviations. The affected lot numbers have expiration dates ranging from March 2022 to December 2022.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II voluntary precautionary recall for manufacturing compliance deviations with no reported illnesses or injuries. The hazard is theoretical, fitting the rubric criterion for 'voluntary precautionary recalls' at severity score 2.
Plain-English summary
Golden State Medical Supply Inc. is recalling Enalapril Maleate Tablets, USP 20 mg, distributed nationwide to customers in Pennsylvania, Massachusetts, Ohio, Texas, Illinois, North Dakota, and Hawaii. Approximately 1,424 bottles with NDC 60429-186-90 are affected, manufactured by Taro Pharmaceutical Industries, Ltd.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. This voluntary recall was initiated by the firm on March 16, 2022, and the FDA classified it as a Class II recall on July 7, 2022.
The affected lot numbers and expiration dates are: GS035031 and GS035199 (expires 03/2022), GS036495 and GS036904 (expires 05/2022), GS037401 (expires 09/2022), GS037986, GS038359, and GS039560 (expires 11/2022), and GS041110 (expires 12/2022).
No illnesses or injuries have been reported in connection with this recall. The recall status remains ongoing.
The recalled product
- Product
- ENALAPRIL MALEATE (ENALAPRIL MALEATE)
- Brand
- ENALAPRIL MALEATE
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug
- Hazard
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Lots: GS035031
- GS035199
- 20 mg
- 90 tablets
- Exp.: 03/2022
- Lots: GS036495
- GS036904
- Exp.: 05/2022
- Lots: GS037401
- Exp.: 09/2022
- Lots: GS037986
- GS038359
- GS039560
- Exp.: 11/2022
- Lot: GS041110
- Exp.: 12/2022. (NDC: 60429-186-90).
Distribution
Distributed nationwide across the United States.
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