D-0016-2021 Class II Terminated
FDA drug recall D-0016-2021 was initiated by Direct Rx on January 15, 2020 and is designated Class II. Reason for recall: CGMP Deviations: Presence of NDMA impurity detected in product. The recall status is terminated (terminated December 7, 2020). Affected quantity: a) 54 bottles; b) 26 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 14, 2020
- Initiation Date
- January 15, 2020
- Termination Date
- December 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 54 bottles; b) 26 bottles
Product Description
Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution Pattern
FL, GA
Code Information
Lots: a) 09AU1911 Exp. 02/28/2022; b) 09SE1904 Exp. 03/31/2022