Skip to content
Recall Observatory FDA recall evidence

Drug product

Hydroxyprogesterone 250 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

D-646-2013

March 20, 2013

Class II

Product summary

Firm
Clinical Specialties Compounding Pharmacy
Event
Event 64661
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-646-2013

Official wording

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

Code information: Lot number CABDAIAB:64, Exp date: 4/8/2013; Lot number CABDAEAB:21, Exp date: 4/4/2013; Lot number CABDBIAB:75, Exp date: 4/18/2013; Lot number CABDAEAC:00, Exp date: 5/5/2013 and Lot number CABDJAC:67, Exp date: 5/20/2013.

Distribution pattern: FL, GA and SC.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility