Methyl Folate Injection Recalled Due to Penicillin Cross Contamination
South Coast Specialty Compounding is recalling Methyl Folate Injection vials due to potential penicillin cross-contamination. The recall covers 335 vials distributed nationwide.
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. According to the rubric, FDA Class II recalls involving significant injury or hospitalization reports are rated as Severe (4). While specific injury reports are not detailed in the text, the agency classification and the nature of the hazard (penicillin contamination in an injectable) align with the Severe criteria for Class II recalls.
Plain-English summary
South Coast Specialty Compounding, Inc. is recalling Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, due to potential cross-contamination with penicillin. The recall affects 335 vials, which correspond to 114 prescriptions. The product was manufactured by Park Compounding in Irving, CA.
The affected lots are # 11152014@1B (Expiration 05/15) and # 02082015@3B (Expiration 08/14). The recall is classified as FDA Class II. The distribution pattern for these products was nationwide.
Patients who have received this medication should consult their healthcare provider. Individuals with a known penicillin allergy should be particularly cautious and seek medical advice if they have used the recalled product.
The recalled product
- Product
- Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
- Manufacturer
- South Coast Specialty Compounding, Inc.
- Category
- Drug — Injectable
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 (3)
- Lot # 11152014@1B
- Exp 05/15 Lot # 02082015@3B
- Exp 08/14
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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