FDA Recalls Prostaglandin Tri-Mix Injection Due to Sterility Concerns
Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix 30:30:1 Injection vials nationwide due to a 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance in an injectable drug) are categorized as Severe.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Prostaglandin Tri-Mix 30:30:1 Injection, 2 mL Vials, manufactured by Anderson Compounding Pharmacy, Inc. The recall is being conducted because the product lacks sterility assurance.
The affected product is distributed nationwide. The recall covers all lots of the medication. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions on how to return or dispose of the medication.
The recalled product
- Product
- Prostaglandin Tri-Mix 30:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Injectable
- 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 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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