Recalls / Class II
Class IID-0615-2020
Product
Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
- Brand name
- Ranitidine
- Generic name
- Ranitidine
- Active ingredient
- Ranitidine Hydrochloride
- Route
- Oral
- NDCs
- 53746-253, 53746-254
- FDA application
- ANDA077824
- Affected lot / code info
- HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4/2021
Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm
- Firm
- Amneal Pharmaceuticals, Inc.
- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, N/A, Brookhaven, New York 11719-9509
Distribution
- Quantity
- N/A
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2019-11-22
- FDA classified
- 2019-12-09
- Posted by FDA
- 2019-12-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0615-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.