FDAFDA · Food and drugs·Recall number D-1424-2012
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)
Published July 25, 2012 · Recall initiated: April 26, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MIDOL COMPLETE
- Manufacturer
- Bayer Healthcare, LLC
- Distributor
- Product was distributed to 93 retail accounts/customers.
- UPC
- 0312843555198
- Lot
- NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.