Methylcobalamin Injection Recalled for Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling Methylcobalamin 1250 mcg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.
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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling Methylcobalamin 1250 mcg/ml, 36ml vials. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes and the assurance of sterility for the product.
The affected product is identified by Lot number CABDCGAC:49 with an expiration date of 3/28/2013. The product was distributed in Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Methylcobalamin 1250 mcg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Injectable
- Affected units
- 36
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)
- Lot number CABDCGAC:49
- Exp date: 3/28/2013.
Distribution
Part of a larger recall action
This product is one of 49 recalled by Clinical Specialties Compounding Pharmacy 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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