United States District Court For the District of New Jersey

United States of America, Plaintiff, v. Barr Laboratories, Inc., et al., Defendants - Page 1

Civil Action No. 92-1744  

ORDER

In accordance with the Court's Opinion filed herewith,

It is on this            day of February, 1993,

ORDERED that plaintiff's motion for a preliminary injunction directing defendants to comply with the Federal Food, Drug and Cosmetic Act is granted in part and denied in part; and it is further

ORDERED that defendant Barr shall produce the data underlying its analytical validation studies relied upon during this proceeding within thirty (30) days of the date of this Order; and it is further

ORDERED that defendant Barr shall submit to the Court and to plaintiff a proposed schedule of validation within ten (10) business days of the entry of this Order, provided, however, that defendant Barr shall complete all validation studies within one year of the date of this Order; and it is further

ORDERED that plaintiff shall submit to the Court and defendant Barr a recommendation regarding the appropriate recall class for each batch Barr must recall, together with evidence supporting their position, within ten business days of the date of this Order, after which time the Court will issue further instructions on the mechanics of the required recall; and it is further

ORDERED that plaintiff's motion is denied with respect to the individual named defendants.

Alfred M. Wolin, U.S.D.J.

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