Abbott's Compounding Pharmacy Recalls Insulin 70/30 Due to Sterility Concerns
Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded Insulin 70/30 after FDA inspection found concerns regarding the lack of sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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 severity score (4) under the rubric, particularly given the risk of infection from non-sterile medical products.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded products, specifically Insulin, 70/30, 10 mL unit size. The recall was initiated after an FDA inspection identified concerns regarding the lack of assurance of sterility for these products.
The affected products were distributed in California. The recall includes all lots of the specified insulin product. No specific lot numbers or expiration dates are provided in the source text, so all unexpired lots are considered affected.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
- Manufacturer
- Abbott's Compounding Pharmacy, Inc.
- Category
- Drug — Compounded Insulin
- 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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