Class II
Ongoing
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
This recall is currently active, issued December 18, 2019. It was issued by Amneal Pharmaceuticals, Inc..
- Company
- Amneal Pharmaceuticals, Inc.
- Recall Initiated
- November 22, 2019
- Posted
- December 18, 2019
- Recall Number
- D-0616-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Brookhaven, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Distribution
Product was distributed throughout the United States.
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
More recalls by Amneal Pharmaceuticals, Inc.
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