Enforcement Report - Week of July 25, 2012
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Product Detail
| 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) |
|---|---|
| Recall Number | D-1424-2012 |
| Classification | Class III |
| Code Info | NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13 |
| Product Distributed Qty | 48,528 cartons |
| 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. |
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. |
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