Status
Ongoing
Drug Enforcement D-0539-2023
Out of specification (OOS) for Spectroscopic Identification test by IR.
Classification
Class II
Report Date
April 26, 2023
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 135 bottles
- Reason for recall
- Out of specification (OOS) for Spectroscopic Identification test by IR.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Ascend Laboratories, LLC
- Address
-
339 Jefferson Rd Ste 101, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0539-2023
- Event ID
- 91918
- Recall initiation date
- March 17, 2023
- Center classification date
- April 19, 2023
- Code info
- Lot #22143120, Exp. Date: June 2024
- More code info
- —