Recalls / Class II
Class IID-0602-2021
Product
BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10
- Brand name
- Buspirone Hydrochloride
- Generic name
- Buspirone Hydrochloride
- Active ingredient
- Buspirone Hydrochloride
- Route
- Oral
- NDCs
- 69584-091, 69584-092, 69584-093, 69584-094
- FDA application
- ANDA075388
- Affected lot / code info
- Lot #: C21021A, Exp. 03/2023
Why it was recalled
Presence of Foreign Tablets/Capsules
Recalling firm
- Firm
- Oxford Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 301 Leaf Lake Pkwy, Birmingham, Alabama 35211-7208
Distribution
- Quantity
- 6,864 bottles
- Distribution pattern
- USA Nationwide.
Timeline
- Recall initiated
- 2021-05-05
- FDA classified
- 2021-06-02
- Posted by FDA
- 2021-06-09
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0602-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.