Recalls / Class II
Class IID-0616-2020
Product
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
- Brand name
- Ranitidine
- Generic name
- Ranitidine
- Active ingredient
- Ranitidine Hydrochloride
- Route
- Oral
- NDCs
- 53746-253, 53746-254
- FDA application
- ANDA077824
- Affected lot / code info
- HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
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-0616-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.