March 2013 FDA Recall Lorazepam by Legacy Pharmaceutical Packaging Llc
D-580-2013 - Labeling
This Class III drug recall was voluntarily initiated by Legacy Pharmaceutical Packaging Llc on March 27, 2013 for the product Lorazepam. The FDA reported the reason for recall as labeling. The product was distributed in Distribution was made to IN. and the recall is currently terminated.
Recall Number: D-580-2013
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
03-27-2013
06-12-2013
1,644 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.
Legacy Pharmaceutical Packaging 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.
Distribution was made to IN.
02-13-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
Batch or Lot Expiration Information
Lot# L-04009 Exp.11/15
