Abbott's Compounding Pharmacy Recalls Methylcobalamine Due to Sterility Concerns
Abbott's Compounding Pharmacy is recalling all unexpired lots of methylcobalamine 4 mg/mL in California due to FDA findings of lack of 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile compounded drug with a lack of sterility assurance, which poses a risk of harm (infection) even though no injuries are reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of methylcobalamine 4 mg/mL in 5 mL and 30 mL unit sizes. The product is a compounded prescription medication available in California.
The recall was initiated after an FDA inspection identified concerns regarding the lack of assurance of sterility for the sterile compounded products. The source text does not specify the number of units recalled or report any illnesses or injuries.
Consumers with this product should contact their healthcare provider or the pharmacy for further instructions on how to proceed.
The recalled product
- Product
- methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
- Manufacturer
- Abbott's Compounding Pharmacy, Inc.
- 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 (1)
- All lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 43 recalled by Abbott's Compounding Pharmacy, Inc. 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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