Why it was recalled
Presence of Foreign Substance: Metal embedded in a tablet.
Product description
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.
Lot numbers, UPCs & expiration codes
Lot AC74459, Exp 07/31/2024
Where it was sold
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-0940-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 13, 2023
- FDA report date
- Aug 2, 2023
- Quantity
- 7313 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0940-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92680
- Address
- 2 Independence Way
- Code information
- Lot AC74459, Exp 07/31/2024
- Postal code
- 08540-6620
- Report date
- Aug 2, 2023
- Product type
- Drugs
- Recall number
- D-0940-2023
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 7313 bottles
- Termination date
- Feb 12, 2024
- Reason for recall
- Presence of Foreign Substance: Metal embedded in a tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 13, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 24, 2023