Anderson Compounding Pharmacy Recalls Prostaglandin Vials Due to Sterility Concerns
Anderson Compounding Pharmacy is recalling Prostaglandin 40 mcg/mL vials 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (lack of sterility assurance) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling Prostaglandin 40 mcg/mL vials. The recall involves 6 vials distributed nationwide. The source text does not specify particular lot numbers, stating instead that all lots are affected.
The reason for the recall is a lack of sterility assurance. The source text does not provide further details regarding specific contamination events or reported illnesses.
Consumers who have this product should contact their healthcare provider or the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Prostaglandin 40 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 6
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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