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.
Product description
Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24
Lot numbers, UPCs & expiration codes
NAA04K6 Exp. 09/13, NAA055P Exp. 09/13, NAA05PA Exp. 09/13
Where it was sold
Product was distributed to 93 retail accounts/customers.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1423-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 26, 2012
- FDA report date
- Jul 25, 2012
- Quantity
- 119,412 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bayer Healthcare, LLC
Original FDA data
Every field from FDA enforcement report D-1423-2012, exactly as published.
Show all FDA fields
- City
- Morristown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 61948
- Address
- 36 Columbia Rd
- Code information
- NAA04K6 Exp. 09/13, NAA055P Exp. 09/13, NAA05PA Exp. 09/13
- Postal code
- 07960-4526
- Report date
- Jul 25, 2012
- Product type
- Drugs
- Recall number
- D-1423-2012
- Classification
- Class III
- Recalling firm
- Bayer Healthcare, LLC
- Product quantity
- 119,412 cartons
- Termination date
- Mar 27, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24
- Distribution pattern
- Product was distributed to 93 retail accounts/customers.
- Recall initiation date
- Apr 26, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 19, 2012