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, 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)
Lot numbers, UPCs & expiration codes
NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13
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-1424-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 26, 2012
- FDA report date
- Jul 25, 2012
- Quantity
- 48,528 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bayer Healthcare, LLC
Original FDA data
Every field from FDA enforcement report D-1424-2012, 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
- NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13
- Postal code
- 07960-4526
- Report date
- Jul 25, 2012
- Product type
- Drugs
- Recall number
- D-1424-2012
- Classification
- Class III
- Recalling firm
- Bayer Healthcare, LLC
- Product quantity
- 48,528 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, 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)
- 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