Why it was recalled
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 7248988B, Exp 9/2023
Where it was sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1330-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 19, 2022
- FDA report date
- Aug 17, 2022
- Quantity
- 1032 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Strides Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-1330-2022, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90634
- Address
- 2 Tower Center Blvd Ste 1102
- Code information
- Lot #: 7248988B, Exp 9/2023
- Postal code
- 08816-1100
- Report date
- Aug 17, 2022
- Product type
- Drugs
- Recall number
- D-1330-2022
- Classification
- Class II
- Recalling firm
- Strides Pharma Inc.
- Product quantity
- 1032 bottles
- Termination date
- Jun 21, 2023
- Reason for recall
- Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- US Nationwide
- Recall initiation date
- Jul 19, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 9, 2022