FDA Recalls Chorionic Gonadotropin Injectable Due to Penicillin Contamination
South Coast Specialty Compounding is recalling Chorionic Gonadotropin/Hydroxocobalamin Injectable vials due to potential penicillin cross-contamination.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of anaphylaxis from penicillin contamination in a drug product.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Chorionic Gonadotropin/Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/5000 mcg per vial. The product is manufactured by Park Compounding in Irving, CA, and recalled by South Coast Specialty Compounding, Inc. The recall involves 337 vials (112 prescriptions) distributed nationwide.
The recall is being conducted because multiple finished products are potentially contaminated with penicillin. This cross-contamination poses a risk to patients with penicillin allergies. The specific lot number is 120322014@1B, with an expiration date of 05/15.
Patients who have received this medication should contact their healthcare provider or pharmacist for guidance. The FDA advises consumers to stop using the product and return it to the pharmacy or clinic where it was obtained.
The recalled product
- Product
- Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
- Manufacturer
- South Coast Specialty Compounding, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 120322014@1B
- Exp 05/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by South Coast Specialty Compounding, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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