Aspercreme, Pain Relieving Creme with Aloe, Maximum Strength Formula, Net Wt 3oz (85g) with Bonus Icy Hot Heat Therapy A
FDA device recall Z-1198-2008 · posted 2008-03-08 · Terminated
Recall details
- Recalling firm
- Chattem Inc
- Reason for recall
- Skin irritation and burns with product usage
- Action taken
- The firm initiated its recall on 02/08/2008 by issuing a press release warning the public of the hazard and directing them to stop its use and either return or discard the products. The firm initiated the recall at the retail level on 02/12/2008 by notifying its employee sales force by email, containing a Urgent Medical Device Recall Letter, with instructions to immediately email a copy of the recall letter to each Chattem consignee (wholesalers and direct retail accounts) with sub recall requests.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IMD
- Quantity affected
- 46,020 units
- Distribution
- Worldwide - USA, Canada, and Honduras
- Date initiated
- 2008-02-12
- Date posted
- 2008-03-08
- Date terminated
- 2009-10-05
- Location
- Chattanooga, TN
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