Anderson Compounding Pharmacy Recalls Prostaglandin Tri-Mix Vials for Sterility Concerns
Anderson Compounding Pharmacy is recalling 58 vials of Prostaglandin Tri-Mix 20:30:1 due to a lack of sterility assurance. The recall covers all lots distributed nationwide.
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 medication) are categorized as Severe (Score 4), particularly when structural defects or significant injury risks are implied by the nature of the defect, even if specific hospitalizations are not explicitly detailed in the brief source text provided.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling 58 vials of Prostaglandin Tri-Mix 20:30:1, 10 mL Vial. The recall was initiated because the product lacks sterility assurance. The affected product was distributed nationwide, and the recall includes all lots.
Prostaglandin Tri-Mix is a compounded medication. The specific hazard identified is the lack of sterility assurance, which poses a risk of contamination. The source text does not specify the exact nature of the contamination or report any specific illnesses or injuries associated with the product.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Compounded Medication
- Affected units
- 58
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
Same manufacturer · Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
See all →- HighAnderson Compounding Pharmacy Recalls Prostaglandin Vials Due to Sterility Concerns
FDA (Drugs) · 2019-04-24
- SevereProstaglandin Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-04-24
- SevereEstrone Oil Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-04-24
- SevereAnderson Compounding Pharmacy Recalls HCG Vials Due to Sterility Concerns
FDA (Drugs) · 2019-04-24
- SevereGentamicin Irrigation Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-04-24
Same hazard · lack of sterility assurance
See all →- SevereNAD+ Pre-Filled Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2025-07-02
- ModerateTirzepatide Injections Pre-filled Syringe Recalled for Sterility Assurance
FDA (Drugs) · 2025-07-02
- HighHydromorphone Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
- HighPHENYLephrine HCl Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
- HighFentanyl Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11