Recalls / Class II
Class IID-0940-2023
Product
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.
- Brand name
- Methylphenidate Hydrochloride
- Generic name
- Methylphenidate Hydrochloride
- Active ingredient
- Methylphenidate Hydrochloride
- Route
- Oral
- NDCs
- 57664-228, 57664-229, 57664-230
- FDA application
- ANDA090710
- Affected lot / code info
- Lot AC74459, Exp 07/31/2024
Why it was recalled
Presence of Foreign Substance: Metal embedded in a tablet.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 7313 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-07-13
- FDA classified
- 2023-07-24
- Posted by FDA
- 2023-08-02
- Terminated
- 2024-02-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0940-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.