FDA Recalls Enalapril Maleate Tablets Over Manufacturing Practice Deviations
Golden State Medical Supply is recalling 31,260 bottles of Enalapril Maleate Tablets due to manufacturing practice deviations.
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 recall with no reported illnesses or injuries. The hazard is manufacturing practice deviations rather than a direct health threat. The voluntary nature and absence of harm reports support a Moderate severity rating.
Plain-English summary
Enalapril Maleate Tablets, USP, 10 mg in 90-tablet bottles are being recalled by packager Golden State Medical Supply Inc. (GSMS) of Camarillo, California. The product was manufactured by Taro Pharmaceutical Industries, Ltd. The recall affects 31,260 bottles with lot numbers ranging from GS027890 through GS041656, with expiration dates from April 2022 through May 2024.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during regulatory review. No illnesses or injuries have been reported in connection with this product.
The affected product was distributed nationwide to patients in Pennsylvania, Massachusetts, Ohio, Texas, Illinois, North Dakota, and Hawaii. Healthcare providers and patients who have received affected lots should take action immediately.
Stop using affected lots and contact Golden State Medical Supply Inc. for instructions on return or replacement. Patients should consult their healthcare provider about obtaining an unaffected alternative to continue their blood pressure medication.
The recalled product
- Product
- ENALAPRIL MALEATE (ENALAPRIL MALEATE)
- Brand
- ENALAPRIL MALEATE
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Prescription
- Hazard
- manufacturing-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: GS027890
- GS028177
- GS028488
- 10 mg
- 90 tablets
- Exp.: 04/2022
- Lots: GS028847
- GS028848
- Exp.: 09/2022
- GS029627
- GS029862
- GS030057
- GS030481
- GS030870
- GS031060
- GS031437
- GS031438
- GS033527
- GS034231
- Exp.: 10/2022
Distribution
Distributed nationwide across the United States.
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