Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.
Reported: March 12, 2014 Initiated: February 4, 2014 #D-1091-2014
Product Description
Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.
Reason for Recall
Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
Details
- Recalling Firm
- Actavis Elizabeth LLC
- Units Affected
- 5,148 bottles
- Distribution
- Nationwide
- Location
- Elizabeth, NJ
Frequently Asked Questions
What product was recalled? ▼
Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.. Recalled by Actavis Elizabeth LLC. Units affected: 5,148 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 12, 2014. Severity: Moderate. Recall number: D-1091-2014.
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