D-0166-2020 Class III Ongoing
FDA drug recall D-0166-2020 was initiated by AuroMedics Pharma LLC on September 23, 2019 and is designated Class III. Reason for recall: CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty. The recall status is ongoing. Affected quantity: 69696 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 6, 2019
- Initiation Date
- September 23, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69696 bottles
Product Description
Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
Reason for Recall
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: NBSB19001DA3, Exp. date 02/2021