Meloxicam Capsules Recalled for Potential Penicillin Cross Contamination
South Coast Specialty Compounding is recalling Meloxicam 12 mg capsules due to potential penicillin cross contamination. The recall covers all lots expiring in August 2015.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 with significant injury reports or high-risk contamination (penicillin cross-contamination in a drug product) are classified as Severe (Score 4).
Plain-English summary
South Coast Specialty Compounding, Inc. is recalling Meloxicam capsules, 12 mg, Rx Only, manufactured by Park Compounding in Irving, CA. The product is a non-sterile formulation containing 40 capsules per prescription.
The recall is being conducted because multiple finished products were potentially contaminated with penicillin. This cross-contamination poses a risk to patients with penicillin allergies.
The recall covers all lots of the product with an expiration date of 08/15. The product was distributed nationwide. Patients and healthcare providers should stop using the recalled product and contact their prescriber for alternatives.
The recalled product
- Product
- Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formulation
- 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 08/15
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.
See all 15 products in this recall →Related recalls
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