D-1423-2012 Class III Terminated
FDA drug recall D-1423-2012 was initiated by Bayer Healthcare, LLC on April 26, 2012 and is designated Class III. Reason for recall: Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour… The recall status is terminated (terminated March 27, 2014). Affected quantity: 119,412 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- July 25, 2012
- Initiation Date
- April 26, 2012
- Termination Date
- March 27, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 119,412 cartons
Product Description
Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24
Reason for Recall
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.
Distribution Pattern
Product was distributed to 93 retail accounts/customers.
Code Information
NAA04K6 Exp. 09/13, NAA055P Exp. 09/13, NAA05PA Exp. 09/13