Reported Jan 15, 2020 · Terminated
Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx…
Appco Pharma LLC
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: Appco Pharma LLC · 262 Old New Brunswick Rd Unit N · Piscataway, NJ · 08854-3756
Is this the product you have?
Ranitidine Capsules 150 mg(a) 60 count bottles (NDC 62559-690-60)(b) 500 count bottles (NDC 62559-690-05)Rx only
- Manufactured byAppco Pharma LLC, Piscataway, NJ 08854
- Distributed byANI Pharmaceuticals, Inc., Baudette, MN 56623
- Lot codes and dates
Batch # 1905225VNexp. date Apr-2021 1905226VDexp. date Apr-2021 1906295UNexp. date May-2021 1906296UNexp. date May-2021 1906297UNexp. date May-2021 1906298UDexp. date May-2021
- Amount recalled
- 624 bottes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
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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