Prescription drug Enalapril Maleate recalled for manufacturing deviations
Golden State Medical Supply Inc. is recalling Enalapril Maleate 2.5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. Approximately 1,471 bottles were distributed nationwide.
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: FDA Class II recall with voluntary firm initiation and no reported illnesses or injuries. CGMP deviations represent manufacturing quality control issues without confirmed patient harm.
Plain-English summary
Enalapril Maleate Tablets, USP 2.5 mg (NDC 60429-183-90) are being recalled by Golden State Medical Supply Inc. The product was manufactured by Taro Pharmaceutical Industries, Ltd., and packaged by Golden State Medical Supply Inc. in California. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations.
Approximately 1,471 bottles are affected by this Class II recall. The affected product was distributed nationwide to patients in Pennsylvania, Massachusetts, Ohio, Texas, Illinois, North Dakota, and Hawaii. Multiple lot numbers are affected, with expiration dates ranging from June 2022 through November 2023. Specific lot information and expiration dates are documented in FDA recall notice D-1177-2022.
No illnesses or injuries have been reported in connection with this recall. Golden State Medical Supply Inc. voluntarily initiated the recall on March 16, 2022.
Patients or healthcare providers who have this medication should contact their pharmacy to determine if they have affected product. Patients should not discontinue their medication without consulting their healthcare provider. Healthcare providers can advise on appropriate next steps, including whether an alternative medication is needed.
The recalled product
- Product
- ENALAPRIL MALEATE (ENALAPRIL MALEATE)
- Brand
- ENALAPRIL MALEATE
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Prescription
- 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 (20)
- Lots: GS028301
- 2.5 mg
- 90 tablets
- Exp.: 06/2022
- Lots: GS029973
- GS029974
- GS031436
- GS031715
- GS033191
- GS033940
- Exp. : 10/2022
- Lot: GS034212
- Exp.: 12/2022
- Lot: GS035315
- GS035945
- GS036905
- GS038038
- GS039199
- Exp.: 04/2023
- Lot: GS039200
Distribution
Distributed nationwide across the United States.
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