Reported Aug 1, 2018 · Terminated
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC#…
Major Pharmaceuticals
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Unit Dose Valsartan Tablets, USP, 80 mg. Rx only
- Distributed byMajor Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Product as published 302086.— — Lot# T-01270 (Expiry: 7/18). — Lot# T-01466 (Expiry: 7/18). — Lot# T-01500 (Expiry:2/19). — Lot# T-01596 (Expiry: 2/19). — Lot# T-01625 (Expiry: 2/19). — Lot# T-01712 (Expiry: 2/19). — Lot# T-01795 (5/19). — Lot# T-01807 (Expiry: 5/19). - Amount recalled
- 5,464 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
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
This product could cause temporary or reversible health problems — stop using it.
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.
Free recall alerts
Get alerted about new Major Pharmaceuticals recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.