D-1424-2012 Class III Terminated
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
- 48,528 cartons
Product Description
Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005-25)
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
NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13