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Recall Observatory FDA recall evidence

Drug product

Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA

D-1341-2015

April 23, 2015

Class II

Product summary

Firm
South Coast Specialty Compounding, Inc.
Event
Event 71078
Status
Terminated
Classification
Class II
Quantity
337 vials (112 prescriptions)
Official record key
drug-enforcement:D-1341-2015

Official wording

Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Code information: Lot # 120322014@1B, Exp 05/15

Distribution pattern: Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.