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FD&C ACT VIOLATIONS OF COUNTERFEITING AND MISBRANDING AMPICILLIN

Executive Summary

FD&C ACT VIOLATIONS OF COUNTERFEITING AND MISBRANDING AMPICILLIN capsules were admitted by former Premo exec John Blackman in New Jersey Federal Court March 5. Blackman pleaded guilty to three criminal misdemeanor counts in connection with the mislabeling and illegal distribution of 1.3 mil. ampicillin capsules in late 1980 and early 1981. According to the indictment, Premo Pharmaceuticals purchased the bulk ampicillin from Pierrel America, based on the U.S. Virgin Islands (St. Croix), in December of 1980. The drugs were labeled with April and June 1981 expiration dates, which Blackman changed to 1984 expiration dates, in addition to falsifying the lot numbers of the drugs. The former Premo VP pleaded guilty to falsifying the expiration dates and lot numbers, and to labeling the ampicillin capsules as Biocraft products. The indictment states that: "Without authorization from Biocraft, he [Blackman] packaged the capsules with copies Biocraft package inserts and labeled them with copies of Biocraft labels, thereby representing them to be the product of . . . Biocraft." Blackman also pleaded guilty to a charge of introducing the misbranded drug into interstate commerce. The ampicillin was delivered to New York pharmacist Jay Greenblatt, who was also indicted. Greenblatt, who was employed by Casson Pharmacy in Queens Village, NY, pleaded guilty to two criminal misdemeanor charges of introducing the misbranded drugs into the interestate commerce. The pharmacy's owner was not indicted. Originally indicted on criminal felony charges, the two men pleaded guilty to reduced criminal misdemeanor counts carrying a maximum sentence of one year in prison and $1,000 fine per count. Blackman could receive a maximum three year prison sentence and $3,000 fine, Greenblatt a maximum two years in prison and $2,000 fine. Sentencing is set for April 13. Blackman, son of Premo President Seymour Blackman, was fired from his position as Premo VP in early 1981 following Premo's discovery of printer's invoices for the counterfeit Biocraft labels and package inserts, and the disappearance of the ampicillin from Premo's New Jersey warehouse.

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