PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 9, 2015 Initiated: April 23, 2015 #D-1341-2015

Product Description

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

Reason for Recall

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

Details

Units Affected
337 vials (112 prescriptions)
Distribution
Nationwide.
Location
Irvine, CA

Frequently Asked Questions

What product was recalled?
Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA. Recalled by South Coast Specialty Compounding, Inc.. Units affected: 337 vials (112 prescriptions).
Why was this product recalled?
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 9, 2015. Severity: Moderate. Recall number: D-1341-2015.