Drug product
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
D-0520-2026
Product summary
- Event
- Event 98794
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 675 bottles
- Official record key
drug-enforcement:D-0520-2026
Official wording
Reason: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Code information: Lot #: GEH25023, Expires: 6/30/2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification