Abbott's Compounding Pharmacy Recalls Folic Acid Due to Sterility Concerns
Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded Folic Acid, 10 mg/mL, after an FDA inspection identified 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 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in a sterile product.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of Folic Acid, 10 mg/mL, 6 mL unit size. The product is a compounded prescription medication that requires refrigeration. The recall is limited to products distributed in California.
The recall was initiated after an FDA inspection found concerns regarding the lack of assurance of sterility for the sterile compounded products. The source text does not specify the number of units recalled, specific lot numbers, or the exact date of the inspection.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
- Manufacturer
- Abbott's Compounding Pharmacy, Inc.
- Category
- Drug — Compounded Prescription
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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