FDAFDA · Food and drugs·Recall number D-0645-2020
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
Published January 15, 2020 · Recall initiated: December 26, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AAA Pharmaceutical, Inc.
- Distributor
- Product was distributed to one consignee who may have distributed the product further to their retail stores.
- Lot
- P134458, Sept 2020 P134943, Aug 2020 P135840, Aug, 2020 P136622, April 2021 P136871, April 2021 P137347, April 2021 P137424, April 2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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