Enforcement Report - Week of July 25, 2012
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Event Detail
| Event ID | 61948 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Bayer Healthcare, LLC |
| City | Morristown |
| State | NJ |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-26 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Product was distributed to 93 retail accounts/customers. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24 | NAA04K6 Exp. 09/13, NAA055P Exp. 09/13, NAA05PA Exp. 09/13 | Class III | 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. | 119,412 cartons | D-1423-2012 |
| 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) | NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13 | Class III | 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. | 48,528 cartons | D-1424-2012 |
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