Recalls / Class III
Class IIID-1424-2012
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)
- Brand name
- Midol Complete
- Generic name
- Acetaminophen, Caffeine, And Pyrilamine Maleate
- Active ingredients
- Acetaminophen, Caffeine, Pyrilamine Maleate
- Route
- Oral
- NDC
- 0280-8005
- FDA application
- M027
- Affected lot / code info
- NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13
Why it was recalled
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.
Recalling firm
- Firm
- Bayer Healthcare, LLC
- Manufacturer
- Bayer HealthCare LLC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 36 Columbia Rd, Morristown, New Jersey 07960-4526
Distribution
- Quantity
- 48,528 cartons
- Distribution pattern
- Product was distributed to 93 retail accounts/customers.
Timeline
- Recall initiated
- 2012-04-26
- FDA classified
- 2012-07-19
- Posted by FDA
- 2012-07-25
- Terminated
- 2014-03-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1424-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.