Reported Aug 1, 2018 · Terminated
Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by
Major Pharmaceuticals
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MAJOR PHARMACEUTICALS · 17177 N Laurel Park Dr · Livonia, MI · 48152-2693
Is this the product you have?
Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India |
| 2 | Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054 |
| 3 | Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 |
| 4 | NDC 0904-5609-61. |
- Lot codes and dates
Lot #: T-01083Exp 08/18DR10447AExp 09/18DS10201AExp 07/19DS10201BDS10201CExp 08/19DS10319AExp 10/19
- Amount recalled
- 3,397 cartons
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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