Class III
Terminated
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)
This recall has been terminated (originally issued July 25, 2012).
- Company
- Bayer Healthcare, Llc
- Recall Initiated
- April 26, 2012
- Posted
- July 25, 2012
- Recall Number
- D-1424-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 48,528 cartons
- Firm Location
- Morristown, NJ, United States
- Official Source
- View on FDA website ↗
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
Product was distributed to 93 retail accounts/customers.
Lot / Code Info
NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13
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