Recalls / Class II
Class IID-0539-2023
Product
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
- Brand name
- Aripiprazole
- Generic name
- Aripiprazole
- Active ingredient
- Aripiprazole
- Route
- Oral
- NDCs
- 67877-430, 67877-431, 67877-432, 67877-433, 67877-434, 67877-435
- FDA application
- ANDA207105
- Affected lot / code info
- Lot #22143120, Exp. Date: June 2024
Why it was recalled
Out of specification (OOS) for Spectroscopic Identification test by IR.
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 135 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-17
- FDA classified
- 2023-04-19
- Posted by FDA
- 2023-04-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0539-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.