Why it was recalled
Presence of Foreign Tablets/Capsules
Product description
BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10
Lot numbers, UPCs & expiration codes
Lot #: C21021A, Exp. 03/2023
Where it was sold
USA Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0602-2021
- Classification
- Class II
- Status
- Completed
- Recall initiated
- May 5, 2021
- FDA report date
- Jun 9, 2021
- Quantity
- 6,864 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Oxford Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0602-2021, exactly as published.
Show all FDA fields
- City
- Birmingham
- State
- AL
- Status
- Completed
- Country
- United States
- Event ID
- 87873
- Address
- 301 Leaf Lake Pkwy
- Code information
- Lot #: C21021A, Exp. 03/2023
- Postal code
- 35211-7208
- Report date
- Jun 9, 2021
- Product type
- Drugs
- Recall number
- D-0602-2021
- Classification
- Class II
- Recalling firm
- Oxford Pharmaceuticals, LLC
- Product quantity
- 6,864 bottles
- Reason for recall
- Presence of Foreign Tablets/Capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10
- Distribution pattern
- USA Nationwide.
- Recall initiation date
- May 5, 2021
- Initial firm notification
- Letter
- Center classification date
- Jun 2, 2021