Reported Nov 6, 2019 · Terminated
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured…
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 Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50
- UPC 342291735507 Manufactured forAvKARE, Inc. Pulaski, TN 38478
- Lot codes and dates
13 of 13 products
Products covered by this recall # Product as published 1 Lot 17708 Exp.11/30/2019 2 Lot 18459 Exp.03/31/2020 3 Lot 19033 Exp.07/31/2020 4 Lot 19032 Exp.07/31/2020 5 Lot 19031 Exp.06/30/2020 6 Lot 20204 Exp.09/30/2020 7 Lot 20205 Exp.09/30/2020 8 Lot 20663 Exp.10/31/2020 9 Lot 20664 Exp.11/30/2020 10 Lot 20665 Exp.11/30/2020 11 Lot 20666 Exp.11/30/2020 12 Lot 21039 Exp.12/31/2020 13 Lot 21920 Exp.04/30/2021 - Amount recalled
- 7293 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
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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