Multi event Drug Recall Enforcement Report Class III voluntary initiated by Bayer Healthcare, LLC, originally initiated on 04-26-2012 for 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 The product was recalled due to 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.. The product was distributed in Product Was Distributed To 93 Retail Accounts/customers. and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1423-2012 | 04-26-2012 | 07-25-2012 | Class III | 119,412 cartons | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24 | 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. | Terminated |
| D-1424-2012 | 04-26-2012 | 07-25-2012 | Class III | 48,528 cartons | 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) | 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. | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0280-8005 | Midol Complete | Acetaminophen, Caffeine, And Pyrilamine Maleate | Tablet | Oral | Bayer Healthcare Llc. | Human Otc Drug |
| 0280-8015 | Midol Complete Gelcaps | Midol Complete | Tablet, Coated | Oral | Bayer Healthcare Llc | Human Otc Drug |
