Recalls / Class II
Class IID-0145-2020
Product
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
- Affected lot / code info
- Lot # PA218P008, PA218P009, Exp 04/2021
Why it was recalled
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, N/A, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 63,216 bottles
- 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.
Timeline
- Recall initiated
- 2019-09-04
- FDA classified
- 2019-10-17
- Posted by FDA
- 2019-10-23
- Terminated
- 2020-02-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0145-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.