Status
Terminated
Drug Enforcement D-1424-2012
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.
Classification
Class III
Report Date
July 25, 2012
Termination Date
March 27, 2014
Product Information
- 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)
- Product quantity
- 48,528 cartons
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to 93 retail accounts/customers.
Location & Firm
- Recalling firm
- Bayer Healthcare, LLC
- Address
-
36 Columbia Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1424-2012
- Event ID
- 61948
- Recall initiation date
- April 26, 2012
- Center classification date
- July 19, 2012
- Code info
- NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13
- More code info
- —