Abbott's Compounding Pharmacy Recalls Methylcobalamine Due to Sterility Concerns
Abbott's Compounding Pharmacy is recalling all unexpired lots of methylcobalamine 1 mg/mL in California due to FDA inspection findings regarding 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 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 recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by lack of sterility assurance in sterile products) fall under the Severe category.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of methylcobalamine 1 mg/mL in 1 mL and 10 mL unit sizes. The product is a compounded prescription medication available in California.
The recall was initiated after an FDA inspection identified concerns regarding a 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 associated with the product.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- methylcobalamine 1 mg/mL, 1 mL and 10 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.
See all 43 products in this recall →Related recalls
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