Reported Jan 15, 2020 · Terminated
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
AAA Pharmaceutical, 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: AAA Pharmaceutical, Inc. · 681 Main St · Lumberton, NJ · 08048-5013
Is this the product you have?
Ranitidine 150 mg tablets130 count bottlesNDC 37808-196-04
- Lot codes and dates
P134457Sept 2020 P135156Aug 2020 P135156Aug 2020 P135243Aug 2020 P135877Sept 2020 P136145Aug 2020 P136146Sept 2020 P136623April 2021 P136728April2021 P136994April2021 P137348April2021 P137423April2021 P137499April2021
- Amount recalled
- 31,536 (130-count bottles)
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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