Specialty Compounding Recalls All Prescription Products Due to Sterility Concerns
Specialty Compounding, LLC is recalling all prescription products manufactured by the company due to a lack of assurance of sterility.
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, which corresponds to a Severe severity score according to the rubric, particularly given the risk of infection associated with non-sterile medical products.
Plain-English summary
Specialty Compounding, LLC has initiated a recall of all prescription-only products manufactured by the company. The recall is being conducted because of a lack of assurance of sterility in the products.
The recall covers all lots of product on the market as of August 9, 2013. The distribution pattern for these products is nationwide.
Consumers who have these products should contact their healthcare provider or pharmacist for further instructions on how to proceed.
The recalled product
- Product
- All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
- Manufacturer
- Specialty Compounding, LLC
- Category
- Drug — Compounded Prescription
- Hazard
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 of product on the market as of August 9
- 2013.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Specialty Compounding, LLC 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 2 products in this recall →Related recalls
Same manufacturer · Specialty Compounding, LLC
See all →- CriticalFDA Recalls Calcium Glucosate Injection Due to Microbial Contamination
FDA (Drugs) · 2014-11-05
Same hazard · lack of sterility
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