D-0617-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 18, 2019
- Initiation Date
- December 2, 2019
- Termination Date
- May 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 316 bottles
Product Description
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution Pattern
CA, FL
Code Information
Lot #: I2519H, Exp. 12/20; I2719O, Exp. 12/20; J1419O, Exp. 12/20; J2819L, Exp. 12/20