Reported Aug 1, 2018 · Terminated
Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India.…
Aidarex Pharmaceuticals LLC
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: Aidarex Pharmaceuticals LLC · 595 N Smith Ave · Corona, CA · 92880-6920
Is this the product you have?
- Enalapril Maleate, USP 5MG, 30-count bottle, RX only
- Packaged ByAidarex Pharmaceuticals
- MfgWockhardt Ltd. India
- NDC33261-0693-30
- Lot codes and dates
- Lots51904-2
- EXP
01/31/201851904-3
- EXP
02/28/201851904-5
- EXP
03/31/201852885-2
- EXP
03/31/201853840-1
- EXP5/28/2018
- Amount recalled
- 25, 30-count bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
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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