Recalls / Class II
Class IID-0844-2022
Product
alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.
- Brand name
- Alprazolam
- Generic name
- Alprazolam
- Active ingredient
- Alprazolam
- Route
- Oral
- NDCs
- 59762-0057, 59762-0059, 59762-0066, 59762-0068
- FDA application
- NDA021434
- Affected lot / code info
- Lot # EH8348, exp. date August 2023
Why it was recalled
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Recalling firm
- Firm
- Viatris Inc
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1000 Mylan Blvd, N/A, Canonsburg, Pennsylvania 15317-5853
Distribution
- Quantity
- 6,789 bottles
- Distribution pattern
- Product was distributed nationwide in the USA
Timeline
- Recall initiated
- 2022-04-28
- FDA classified
- 2022-05-03
- Posted by FDA
- 2022-05-11
- Terminated
- 2023-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0844-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.