FDAFDA · Food and drugs·Recall number D-0646-2020
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
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
- P134457, Sept 2020 P135156, Aug 2020 P135156, Aug 2020 P135243, Aug 2020 P135877, Sept 2020 P136145, Aug 2020 P136146, Sept 2020 P136623, April 2021 P136728, April, 2021 P136994, April, 2021 P137348, April, 2021 P137423, April, 2021 P137499, April, 2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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