May 2018 FDA Recall Hydrocodone Bitartrate And Acetaminophen by Lupin Somerset
D-0836-2018 - Labeling
This Class III drug recall was voluntarily initiated by Lupin Somerset on May 24, 2018 for the product Hydrocodone Bitartrate And Acetaminophen. The FDA reported the reason for recall as labeling. The product was distributed in OH and the recall is currently terminated.
Recall Number: D-0836-2018
Labeling: Missing Label
05-24-2018
06-06-2018
1,672 (1000-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 SOMERSET
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.
OH
01-26-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102
Batch or Lot Expiration Information
Lot# S800257; Exp. 01/20
