D-0639-2020 Class II Ongoing
FDA drug recall D-0639-2020 was initiated by Glenmark Pharmaceuticals Inc., USA on December 17, 2019 and is designated Class II. Reason for recall: CGMP Deviations: Presence of NDMA impurity detected in product. The recall status is ongoing. Affected quantity: 208,668 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 15, 2020
- Initiation Date
- December 17, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 208,668 bottles
Product Description
Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution Pattern
Natiowide
Code Information
7701164A 7701471A 7701670B 7701827A 7702242A 7702705A 7702947A 7703408A 7704494A 7704495A 19190289 19190342 19190372 7702737A