Reported Apr 17, 2019 · Terminated
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478…
AVKARE Inc.
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: AVKARE Inc. · 615 N 1st St · Pulaski, TN · 38478-2403
Is this the product you have?
- Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only
- Manufactured forAvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
- Lot codes and dates
- Lots
201916 Exp. 08/201920092 Exp. 08/2019
- Lots
- Amount recalled
- 397 bottles
Where it was sold
Why it was recalled
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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