FDA Recalls Prostaglandin Tri-Mix Vials Due to Sterility Concerns
Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix 50:30:1 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 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 rubric specifies that an FDA Class II recall involving a significant risk, such as a lack of sterility assurance in an injectable medication, is classified as Severe (Score 4).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Prostaglandin Tri-Mix 50:30:1, 10 mL Vials manufactured by Anderson Compounding Pharmacy, Inc. The recall involves 31 vials distributed nationwide. The agency has classified this as a Class II recall.
The recall was initiated because of a lack of sterility assurance in the product. The source text does not specify which lot numbers are affected, nor does it report any specific illnesses or injuries associated with the use of these vials.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The recall is voluntary and precautionary in nature regarding the sterility of the medication.
The recalled product
- Product
- Prostaglandin Tri-Mix 50:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 31
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.
See all 68 products in this recall →Related recalls
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