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Recall Observatory FDA recall evidence

Drug product

Medroxyprogesterone 150 mg/ml,Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

D-651-2013

March 20, 2013

Class II

Product summary

Firm
Clinical Specialties Compounding Pharmacy
Event
Event 64661
Status
Terminated
Classification
Class II
Quantity
220ml total
Official record key
drug-enforcement:D-651-2013

Official wording

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

Code information: Lot number CABDDBAB:21, Exp date: 7/30/2013; Lot number CABCBBBA:65, Exp date: 4/9/2013; Lot number CABCBBBA:77, Exp date: 4/9/2013; Lot number CABCBBBA:20 , Exp date: 4/9/2013; Lot number CABCCFBA:42, Exp date: 4/23/2013; Lot number CABCCFBA:59, Exp date: 4/23/2013; Lot number CABCCFBA:76, Exp date: 4/23/2013; Lot number CABCCFBA:85, Exp date: 4/23/2013; Lot number CABCCHBB:28, Exp date: 5/23/2013; Lot number CABCCHBB:46, Exp date: 5/23/2013; Lot number CABCCHBB:87, Exp date: 5/26/2013; Lot number CABCCHBB:30, Exp date: 5/26/2013; Lot number CABCBJBC:92, Exp date: 6/17/2013; Lot number CABCBJBC:93, Exp date: 6/17/2013; Lot number CABCBJBC:31, Exp date: 6/17/2013; Lot number CABDAIAC:21, Exp date: 8/7/2013; Lot number CABDDBAB:05, Exp date: 7/30/2013; Lot number CABDDBAB:03, Exp date: 7/30/2013; Lot numberCABDDBAB:43, Exp date: 7/30/2013; Lot number CABDAIAC:45, Exp date: 8/7/2013 and Lot number CABDAIAC:13, Exp date: 8/7/2013.

Distribution pattern: FL, GA and SC.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility