December 2021 FDA Recall Oxycodone Hydrochloride by Lupin Pharmaceuticals Inc.
D-0358-2022 - Out-of-specification impurity test result observed at 18-month long term stability time point.
This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on December 29, 2021 for the product Oxycodone Hydrochloride. The FDA reported the reason for recall as out-of-specification impurity test result observed at 18-month long term stability time point.. The product was distributed in Product Distributed in NY and OH. and the recall is currently terminated.
Recall Number: D-0358-2022
Out-of-specification impurity test result observed at 18-month long term stability time point.
12-29-2021
01-12-2022
23,965 100 count bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
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.
Product Distributed in NY and OH.
08-23-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01
Batch or Lot Expiration Information
Lot# S000268, Exp. date January 2022
