Reported Dec 4, 2019 · Terminated
AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC…
AVKARE Inc.
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: AVKARE Inc. · 615 N 1st St · Pulaski, TN · 38478-2403
Is this the product you have?
- AVKARE Ranitidine Tablets
- USP 300 mg Rx Only NDC Manufactured forAvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
- Lot codes and dates
- Lots
a) 21307 Exp. 02/29/202021309 Exp. 02/29/202021528 Exp. 02/29/202021527 Exp. 02/29/202022247 Exp. 06/30/202023214 Exp. 09/30/202023243 Exp. 09/30/202023244 Exp. 11/30/202024198 Exp. 01/31/202124199 Exp. 01/31/202124289 Exp. 01/31/2021b) 22291 Exp. 06/30/202023215 Exp. 09/30/202023776 Exp. 01/31/2021
- Lots
- Amount recalled
- 104,797 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
This product could cause temporary or reversible health problems — stop using it.
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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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