Abbott's Compounding Pharmacy Recalls Sterile Methylcobalamine Due to Sterility Concerns
Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile methylcobalamine injections because an FDA inspection found concerns regarding the assurance of sterility.
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 medical product with a lack of sterility assurance, which poses a risk of harm (infection) even though no specific illnesses or injuries are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded methylcobalamine 10 mg/mL. The affected products are available in 10 mL and 12 mL unit sizes and are distributed in California.
The recall was initiated after an FDA inspection identified concerns regarding the lack of assurance of sterility for these sterile compounded products. The source text does not specify a particular lot number, stating that all unexpired lots are affected.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the pharmacy for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
- Manufacturer
- Abbott's Compounding Pharmacy, Inc.
- 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.
See all 43 products in this recall →Related recalls
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