Reported Jan 15, 2020 · Terminated
Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854,…
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 300 mg30 count bottles. Rx only
- Manufactured byAppco Pharma LLC, Piscataway, NJ 08854
- Distributed byANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30
- Lot codes and dates
Batch # 1905227UEexp. date Apr-2021 1905228UEexp. date Apr-2021
- Amount recalled
- 1,632 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.
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 Appco Pharma LLC 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.