Abbott's Compounding Pharmacy Recalls Sterile Calcium Compounds for Sterility Concerns
Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded calcium products 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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While no injuries are reported, the lack of sterility assurance in a sterile product represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious harm.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded products, specifically calcium elemental, 3 mg/10 mL, 200 mL units. The recall is limited to products distributed in California.
The recall was initiated after an FDA inspection identified concerns regarding the lack of assurance of sterility for these compounded products. The source text does not specify a particular lot number, stating instead that all unexpired lots are affected.
Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- calcium elemental, 3 mg/10 mL, 200 mL unit: 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.
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