Recalls / Class II
Class IID-0011-2019
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 #: PA26038A, Exp 04/19; PA26039A, PA26040A, PA26050A, Exp 05/19; PA26052A, Exp 06/19; PA26073A, Exp 07/19; PA217071A, PA217072A, PA217073B, PA217074B, Exp 06/20; PA217101A, Exp 08/20; and PA218023A, Exp 01/21.
Why it was recalled
Discoloration: Presence of dark discoloration or brown spots on the edges of the 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
- 158,466 bottles
- Distribution pattern
- Product was distributed Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2018-10-02
- FDA classified
- 2018-10-09
- Posted by FDA
- 2018-10-17
- Terminated
- 2020-02-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0011-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.