Leucovorin Calcium Capsules Recalled for Potential Penicillin Contamination
South Coast Specialty Compounding is recalling Leucovorin Calcium capsules due to potential penicillin cross-contamination. The affected products were 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury risks or hospitalization reports are rated as Severe (4). Penicillin contamination in a drug product presents a significant risk of severe allergic reaction.
Plain-English summary
South Coast Specialty Compounding, Inc. is recalling Leucovorin Calcium capsules, 10 mg, which are prescription-only medications. The recall involves 2,355 capsules across 26 prescriptions. The products were manufactured by Park Compounding in Irvine, California, and are identified by the expiration date 06/15.
The recall was initiated because multiple finished products were potentially contaminated with penicillin. This cross-contamination poses a risk to patients who may be allergic to penicillin. The affected products were distributed nationwide.
Consumers and healthcare providers should stop using the recalled Leucovorin Calcium capsules immediately. Patients should contact their healthcare provider for alternative treatment options. The recalling firm is South Coast Specialty Compounding, Inc.
The recalled product
- Product
- Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA
- Manufacturer
- South Coast Specialty Compounding, Inc.
- Category
- Drug — Prescription Medication
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)
- All Lots
- Exp 06/15
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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