Recalls / Class II
Class IID-1058-2020
Product
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90
- Affected lot / code info
- Lot # PA218005A, exp. date 12/2020, PA218P010, PA218P011, exp. date 04/2021, PA218108A, PA218110A, exp. date 06/2021
Why it was recalled
CGMP Deviations: 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, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 89,376 90-count bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-03-11
- FDA classified
- 2020-03-24
- Posted by FDA
- 2020-03-25
- Terminated
- 2020-06-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1058-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.