Enforcement Report - Week of March 13, 2013
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Product Detail
| Product Description | Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-5), Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA. |
|---|---|
| Recall Number | D-187-2013 |
| Classification | Class III |
| Code Info | Lot# 71648, 68088; FP-47-041-02535 |
| Product Distributed Qty | 5,676 bottles (473 cases) |
| Reason For Recall | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. |
Event Detail
| Event Id | 64298 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Aaron Industries Inc |
| City | Lynwood |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-18 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Nationwide |
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