Skip to content
Recall Observatory FDA recall evidence

Drug product

Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

D-660-2013

March 20, 2013

Class II

Product summary

Firm
Clinical Specialties Compounding Pharmacy
Event
Event 64661
Status
Terminated
Classification
Class II
Quantity
96ml total
Official record key
drug-enforcement:D-660-2013

Official wording

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

Code information: Lot number CABDBFAC:52, Exp date: 5/16/2013; Lot number CABDBBAB:40, Exp date: 4/11/2013; Lot number CABDCAAC:15, Exp date: 5/21/2013; Lot number CABDCCAC:75, Exp date: 5/23/2013 and Lot number CABDAFAD:77, Exp date: 6/3/2013.

Distribution pattern: FL, GA and SC.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility