Enforcement Report - Week of March 13, 2013
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Product Detail
| Product Description | Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011 |
|---|---|
| Recall Number | D-186-2013 |
| Classification | Class III |
| Code Info | Lot# 68089, 68415, 70046, 700516, 70665, 71157, 71704, 80795; FP-38-081-57313; FP-38-041-57307 |
| Product Distributed Qty | 35,652 bottles (2,971 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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