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)
Reported: July 25, 2012 Initiated: April 26, 2012 #D-1424-2012
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)
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.
Details
- Recalling Firm
- Bayer Healthcare, LLC
- Units Affected
- 48,528 cartons
- Distribution
- Product was distributed to 93 retail accounts/customers.
- Location
- Morristown, NJ
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Bayer Healthcare, LLC. Units affected: 48,528 cartons.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 25, 2012. Severity: Low. Recall number: D-1424-2012.
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