FDAFDA · Food and drugs·Recall number D-0539-2023
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
Published April 26, 2023 · Recall initiated: March 17, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Out of specification (OOS) for Spectroscopic Identification test by IR.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ARIPIPRAZOLE
- Manufacturer
- Ascend Laboratories, LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot #22143120, Exp. Date: June 2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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