Estrone Oil Injection Recalled for Lack of Sterility Assurance
Anderson Compounding Pharmacy is recalling Estrone 5mg/mL Oil Injection nationwide due to a 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. Lack of sterility assurance in an injectable drug poses a significant risk of infection.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling Estrone 5mg/mL Oil Injection, 10 mL Vials, distributed nationwide. The recall was initiated because the product lacks sterility assurance.
The recall covers all lots of the product. The source text does not specify the number of units affected or the specific dates of distribution.
Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Injectable
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 nationwide across the United States.
Part of a larger recall action
This product is one of 68 recalled by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy 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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