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
Reported: April 26, 2023 Initiated: March 17, 2023 #D-0539-2023
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
Reason for Recall
Out of specification (OOS) for Spectroscopic Identification test by IR.
Details
- Recalling Firm
- Ascend Laboratories, LLC
- Units Affected
- 135 bottles
- Distribution
- Nationwide in the USA
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ascend Laboratories, LLC. Units affected: 135 bottles.
Why was this product recalled? ▼
Out of specification (OOS) for Spectroscopic Identification test by IR.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 26, 2023. Severity: Moderate. Recall number: D-0539-2023.
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