Recalls / Class II
Class IID-1074-2019
Product
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 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 #: PA217060A, Exp 05/2020
Why it was recalled
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the 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
- 12,960 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2019-03-29
- FDA classified
- 2019-04-01
- Posted by FDA
- 2019-04-10
- Terminated
- 2019-09-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1074-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.