Multi-event April 2012 FDA Recall Midol Complete by Bayer Healthcare, Llc
This Multi-event Class III drug recall was voluntarily initiated by Bayer Healthcare, Llc on April 26, 2012 for the product Midol Complete. The FDA reported the reason for recall as labeling. The product was distributed in Product was distributed to 93 retail accounts/customers. and the recall is currently terminated.
Reported Recall Events
Recall Number: 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.
04-26-2012
07-25-2012
48,528 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Bayer Healthcare, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 93 retail accounts/customers.
03-27-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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)
Batch or Lot Expiration Information
Lot# NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13
Affected Packages Involved in this Recall
Recall Number: D-1423-2012
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.
04-26-2012
07-25-2012
119,412 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Bayer Healthcare, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 93 retail accounts/customers.
03-27-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24
Batch or Lot Expiration Information
Lot# NAA04K6 Exp. 09/13, NAA055P Exp. 09/13, NAA05PA Exp. 09/13
