BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10

FDA recall notice · announced June 9, 2021 · Oxford Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10

Reason for recall

Presence of Foreign Tablets/Capsules

Notes

Distribution: USA Nationwide.
Lot/code information: Lot #: C21021A, Exp. 03/2023
Quantity: 6,864 bottles
Status: Completed
Products in this recall event:
- BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10 (D-0602-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.