Aspercreme, Pain Relieving Creme with Aloe, Maximum Strength Formula, Net Wt 3oz (85g) with Bonus Icy Hot Heat Therapy Air Activated Heat Patch, 1 individually wrapped patch, 3.9" x 5.3" (10cm x 13.5cm), Distributed by Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219
- Company
- Chattem Inc
- Recall Initiated
- February 12, 2008
- Posted
- March 8, 2008
- Terminated
- October 5, 2009
- Recall Number
- Z-1198-2008
- Quantity
- 46,020 units
- Firm Location
- Chattanooga, TN
Reason for Recall
Skin irritation and burns with product usage
Distribution
Worldwide - USA, Canada, and Honduras
Lot / Code Info
Only those Aspercreme units that have the "bonus packs" containing any lot of the Icy Hot Heat Therapy patches.
Root Cause
Device Design
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.
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