D-0145-2020 Class II Terminated
FDA drug recall D-0145-2020 was initiated by Jubilant Cadista Pharmaceuticals, Inc. on September 4, 2019 and is designated Class II. Reason for recall: CGMP Deviation: Presence of dark brown discoloration on edges of tablets. The recall status is terminated (terminated February 12, 2020). Affected quantity: 63,216 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 23, 2019
- Initiation Date
- September 4, 2019
- Termination Date
- February 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63,216 bottles
Product Description
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90
Reason for Recall
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Distribution Pattern
Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.
Code Information
Lot # PA218P008, PA218P009, Exp 04/2021