May 2021 FDA Recall Buspirone Hydrochloride by Oxford Pharmaceuticals, Llc
D-0602-2021 - Presence of Foreign Tablets/Capsules
This Class II drug recall was voluntarily initiated by Oxford Pharmaceuticals, Llc on May 5, 2021 for the product Buspirone Hydrochloride. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0602-2021
Presence of Foreign Tablets/Capsules
05-05-2021
06-09-2021
6,864 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Oxford Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# : C21021A, Exp. 03/2023
