Able Labs Recall Of All Marketed Products Boosts 2005 Drug Recall Total

Generic drug manufacturer Able Laboratories' recall of all of its marketed products following an FDA GMP inspection accounted for half of the substantial rise of products recalled during 2005 versus the previous year.

Forty-five of the 254 products included in the FDA recall listings for 2005 were manufactured at Able's New Jersey facilities. In 2004, there were 170 products recalled.

FDA listed the reason for the majority of the Able recalls as "lack of assurance that testing for release and stability conformed to SOPs." Another four products, the agency listing explains, were "recalled at the request of the manufacturer due to concerns that the product was not made in accordance with quality standards."

The bulk of the Able recalls followed an FDA inspection that began in early May 2005 and ended two months later (¹ (Also see "FDA Cites Able For Failing To Reject Out-Of-Specification Drugs, Altering Data" - Pink Sheet, 18 Jul, 2005.), p. 31).

Able's experience shows the sudden and dramatic impact that GMP compliance problems can have on a firm's financial health. Following the product-wide recall, the firm shut down its operations, filed for Chapter 11 bankruptcy protection and sold off its remaining assets.

Despite the recalls by Able, last year's totals were not historically conspicuous. The annual recall average over the past decade was just over 240 products and those yearly totals have oscillated around that number with no clear trend.

The highest tally for the decade came in 2000, when 464 products were recalled. However, that number included an action involving more than 200 mostly oral solid products repacked by Pharmaceutical Corporation of America. PCA went out of business after a GMP inspection led to disclosures that forced the recall action.

In only one other year, 1999, were more than 300 recalls recorded (338). In that case, the target was Schein's two manufacturing subsidiaries, Steris and Marsam, who together accounted for 128 injectable products in the 1999 recall tally.

The lowest number of product recalls recorded was 154 in 1998, followed by last year's total of 170.

Able's products contributed to a spike in the number of oral solid recalls during 2005, to 119 from 73 a year earlier. Altogether, oral solids made up half of the 254 recalls for 2005. Oral liquids was the second most frequently recalled dosage form during the year, although the number (35) was roughly 30% of the oral solids total. Injectables were third on the list with 30 recalls.

Able's 39 entries in "manufacturing/test methods," helped make the category a leading reason for recalls in 2005, sharing the top spot with contamination/sterility assurance.

As is the case for "lack of assurance of sterility," recalls falling into the GMP category are generally prompted by adverse FDA inspection findings. There were six other firms that conducted recalls in this category in 2005.

Recall-prompting problems with contamination and sterility assurance almost doubled, to 47 from 24 a year earlier.

Intimately involved in the recall process for biologics are biological product deviation reports (BPDRs) - a vehicle for reporting problems discovered in the manufacturing, testing and distribution that can affect the safety/quality of marketed products.

The reports are categorized into the type of problem/ system involved. The categories are: incoming material specifications; process controls; testing; labeling; product specs; quality control and distribution; and miscellaneous.

Non-blood BPDR filings to the Center for Biologics Evaluation & Research increased from 333 in fiscal year 2004 to 387 this past year, reflecting an uptick in allergenic product filings (158 to 200).

The deviation type drawing the highest number of BPDRs was product specifications. About 60% of all non-blood reports filed to CBER (235 of 387) fell into this category. Labeling problems were the second most common source - doubling to 75 from the previous year's total of 37.

[Editor's note: A full listing and detailed analysis of drug product recalls for 2005 as well as the recent data on biological product deviation reports are provided in the February issue of "The Gold Sheet."]