Recalls / Class II
Class IID-1330-2022
Product
Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.
- Brand name
- Prednisone
- Generic name
- Prednisone
- Active ingredient
- Prednisone
- Route
- Oral
- NDCs
- 64380-784, 64380-785, 64380-949
- FDA application
- ANDA208412
- Affected lot / code info
- Lot #: 7248988B, Exp 9/2023
Why it was recalled
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Recalling firm
- Firm
- Strides Pharma Inc.
- Manufacturer
- Strides Pharma Science Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1102, East Brunswick, New Jersey 08816-1100
Distribution
- Quantity
- 1032 bottles
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2022-07-19
- FDA classified
- 2022-08-09
- Posted by FDA
- 2022-08-17
- Terminated
- 2023-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1330-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.