D-0617-2020 Class II Terminated

Recalled by Preferred Pharmaceuticals, Inc — Anaheim, CA

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