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WHITEHALL CLASS II RECALL OF 19.3 MIL. ARTHRITIS PAIN FORMULA CAPLETS

This article was originally published in The Tan Sheet

Executive Summary

WHITEHALL CLASS II RECALL OF 19.3 MIL. ARTHRITIS PAIN FORMULA CAPLETS was due to a malfunction in the company's granulation processing equipment that has since been corrected, the company reports. The retail-shelf level recall involves seven lots of Arthritis Pain Formula buffered aspirin caplets. To date, about two-thirds of the recalled product has been returned to the manufacturer. The problem was detected by operators who heard an unfamiliar noise coming from the granulation processor, a Whitehall spokesperson explained. The company believes that the problem occurred within a 15 minute time span. However, as a precaution, the recall covers all product manufactured over the previous week, dating back to the last time the processor had been cleaned. Whitehall announced the nationwide recall in a Dec. 8, 1992 mailing ("The Tan Sheet" March 15, p.13). The American Home Products subsidiary initiated the recall due to the "possibility" that "a small amount of metallic particles might be found in a very few caplets." The recall letter notes that "similar recalls have been previously categorized as Class II" by FDA. The recall letter asks those companies with Arthritis Pain Formula caps in warehouse stock or on the retail shelves to review the lot numbers. Customers also are being asked to "immediately notify all of [their] accounts and intermediate distributors who may have purchased these recall lots [that they] should examine their inventory of Arthritis Pain Formula caplets in warehouse stock or on the retail shelves and remove and isolate any recalled lots for subsequent return." For returned merchandise, Whitehall is offering credit or replacement goods. The seven lots of Arthritis Pain Formula covered by the recall include: Lot numbers D229 (expiring 4/96), D230 (expiring 4/96) and E220 (expiring 5/96), all bottles of 40 caplets; lot numbers E213 (expiring 5/96), E214 (expiring 5/96) and E228 (expiring 5/96), all bottles of 100 caplets; and lot number E222 (expiring 5/96), all bottles of 175 caplets. Approximately a 65% return was reported by the company from its first mailing in December. A subsequent notice of the recall has been sent out and the company has not yet tallied the returns from that mailing. Whitehall expects the recall to be completed by this summer. In early 1992, a metal shavings problem at a Rhone-Poulenc bulk aspirin facility led to at least six large recalls of aspirin-containing finished product ("The Tan Sheet" March 1, p. 20). The problem at the Rhone-Poulenc plant has since been addressed. Although Rhone-Poulenc is the bulk aspirin supplier for Arthritis Pain Formula caps, the recall is due to a manufacturing problem that occurred at Whitehall.

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