Clinical Specialties Compounding Pharmacy Recalls Methylcobalamin Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling specific lots of Methylcobalamin 12.5 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.
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 quality control failures (such as lack of sterility assurance) are categorized as Severe (Score 4), particularly when no specific hospitalization reports are cited but the defect is significant.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling specific lots of Methylcobalamin 12.5 mg/ml. The recall was initiated following FDA inspection findings that resulted in concerns regarding the quality control processes used to ensure the sterility of the product.
The affected product is distributed in Florida, Georgia, and South Carolina. The recall covers specific lot numbers with expiration dates ranging from April 2013 to August 2013. The total quantity involved is 95ml.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the pharmacy or the recalling firm for disposal or credit, as directed by the company.
The recalled product
- Product
- Methylcobalamin 12.5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 95
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 (5)
- Lot number CABCBJBA:55
- Exp date: 4/17/2013
- Exp date: Lot number CABDCCAB:52
- Exp date: 7/21/2013 and Lot number CABDCGAC:50
- Exp date: 8/25/2013.
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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