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Recall Observatory FDA recall evidence

Drug product

Test Cyp 100 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

D-665-2013

March 20, 2013

Class II

Product summary

Firm
Clinical Specialties Compounding Pharmacy
Event
Event 64661
Status
Terminated
Classification
Class II
Quantity
219ml total
Official record key
drug-enforcement:D-665-2013

Official wording

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Code information: Lot number CABCBFBA:15, Exp date: 4/13/2013; Lot number CABCACBA:58, Exp date: 3/31/2013; Lot number CABCAHBB:54, Exp date: 5/6/2013; Lot number CABCCHBB:63, Exp date: 5/26/2013; Lot number CABCAFBC:31, Exp date: 6/3/2013; Lot number CABCCHBS:23, Exp date: 6/25/2013; Lot number CABDBAAB:64, Exp date: 7/9/2013; Lot number CABDAIAB:59, Exp date: 7/7/2013; Lot number CABDAFAC:48, Exp date: 8/4/2013; Lot number CABDBJAC:27, Exp date: 8/18/2013 and Lot number CABDABAD:61, Exp date: 8/28/2013.

Distribution pattern: FL, GA and SC.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility