FDA Drug Recalls Down In 1995

5 February 1996

The US Food and Drug Administration has revealed that it recalled a total of 189 pharmaceutical products in 1995, a decline of 29.7% over 1994's figure of 269.

135 prescription drug products were recalled last year, compared with 200 in the previous year. A major contributory factor to this reduction is reported to be a significant decline in the number of recalls on the grounds of lack of bioequivalence assurance/Abbreviated New drug Application discrepancies; these had become a major problem in the wake of the generic industry FDA bribery scandals of 1989, and had accounted for around 10% of recalls annually after the problem was discovered.

67 oral solid prescription drugs were recalled in 1995, down from 113 in 1994, and 22 injectable products were recalled, against 37. The FDA reported 59 recalls of over-the-counter drugs in 1995, down from 69 in 1994.

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