Agency classClass IIOur severity:Severe FDA (Drugs)·D-655-2013·Announced 2013-07-10

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.

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 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: sterility
quality-control
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

Distributed in 3 states:

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.

See all 49 products in this recall →

Same manufacturer · Clinical Specialties Compounding Pharmacy

See all →

Severe
Avastin Syringes Recalled for Sterility Concerns and Eye Infection Reports
FDA (Drugs) · 2013-09-04
Severe
Clinical Specialties Compounding Pharmacy Recalls Test Cyp 250 mg-lidocaine 5 mg/ml
FDA (Drugs) · 2013-07-10
Severe
Estradiol Cypionate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2013-07-10
Severe
Clinical Specialties Compounding Pharmacy Recalls Test Cyp 200 mg/ml Due to Sterility Concerns
FDA (Drugs) · 2013-07-10
Severe
Clinical Specialties Compounding Pharmacy Recalls Test Cyp 100 mg/ml Due to Sterility Concerns
FDA (Drugs) · 2013-07-10

Same hazard · sterility