FDA Recall D-0539-2023
Ascend Laboratories, LLC · Parsippany, NJ
Class II Ongoing 1154 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Out of specification (OOS) for Spectroscopic Identification test by IR.
Recall record
- Recall number
D-0539-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2023-03-17
- Classified by FDA Center
- 2023-04-19
- FDA published
- 2023-04-26
- Recalling firm
- Ascend Laboratories, LLC
- Firm location
- Parsippany, NJ
Drug identification
- Brand name(s)
- ARIPIPRAZOLE
- Generic name(s)
- ARIPIPRAZOLE
- Manufacturer(s)
- Ascend Laboratories, LLC
- NDC(s)
67877-430, 67877-431, 67877-432, 67877-433, 67877-434, 67877-435- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.