Reported Dec 19, 2018 · Ongoing
Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC…
Teva Pharmaceuticals USA
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: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
- Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only
- Manufactured In Israel ByTEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel
- Manufactured ForTEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454
- Lot codes and dates
- NDC 0093-7690-56 & NDC 0093-7690-98 Lot # 23X017, 23X018, 23X019, 23X020, 23X022, 23X023, 23X024
- Amount recalled
- 120,394 bottles
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in 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 Teva Pharmaceuticals USA 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.