ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9, Wyeth Consumer Healthcare, P.O. Box 26609, Richmond, VA 23261-6609
This recall has been terminated (originally issued December 16, 2010).
- Company
- Pfizer Global
- Recall Initiated
- September 24, 2010
- Posted
- December 16, 2010
- Terminated
- September 16, 2011
- Recall Number
- Z-0622-2011
- Quantity
- 192000 cartons (3 wraps per carton)
- Firm Location
- Madison, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
The chemical components contained in the heat wrap may leak directly onto the skin, which could cause skin injury, including burns.
Distribution
Nationwide Distribution: Throughout the U.S. and Puerto Rico.
Lot / Code Info
Lot number: E06831 (Exp 8/2012); The lot number on the 3 ct cartons may be followed by an "N" or "S", for example, E06831 "N" or E06831 "S"
Root Cause
Packaging process control
Action Taken
Wyeth Consumer Healthcare issued an Urgent Voluntary Medical Device Recall letter dated September 24, 2010 to direct accounts, and issued a press release. The firm is removing the product in question from store shelves and asking consumers who have purchased the product to record the lot number, throw the product away in its entirety without opening the foil pouch and call 1 800 232-3383 for replacement. Direct accounts were instructed to remove the affected product from sale and return it immediately. If they further distributed the product they were instructed to notify their customers of the recall and request return of the products to them credit. Instructions were provided in the event consumers inquired about the recall. A prepaid post card was enclosed to record the quantity on hand to be returned.