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
- Recalling Firm
- South Coast Specialty Compounding, Inc.
- 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.
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