American Specialty Pharmacy Recalls Hydroxocobalamin Injection Due to Particulate Matter
American Specialty Pharmacy is recalling 15 vials of Hydroxocobalamin Injection Solution 1 mg/mL due to the presence of particulate matter and potential preservative issues.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter and preservative issues without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
American Specialty Pharmacy, located in Plano, Texas, is recalling 15 vials of Hydroxocobalamin Injection Solution 1 mg/mL. The product is identified by NDC 99999-9994-27 and Lot# 10082014@10. The recall was initiated because of the presence of particulate matter in the solution, as well as the possibility that the preservative may not have dissolved completely or may have precipitated out of the product.
The affected product was distributed in Texas. This recall is classified as Class II by the U.S. Food and Drug Administration. Consumers and healthcare providers who have this specific lot of Hydroxocobalamin Injection Solution should stop using it and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27
- Manufacturer
- American Specialty Pharmacy
- Category
- Drug — Injection
- Affected units
- 15
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 (1)
- Lot# 10082014@10
Distribution
Distributed in 1 state:
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