Drug product
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)
D-1424-2012
Product summary
- Event
- Event 61948
- Status
- Terminated
- Classification
- Class III
- Quantity
- 48,528 cartons
- Official record key
drug-enforcement:D-1424-2012
Official wording
Reason: 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.
Code information: NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13
Distribution pattern: Product was distributed to 93 retail accounts/customers.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up