Prostaglandin Vials Recalled Due to Lack of Sterility Assurance
Anderson Compounding Pharmacy is recalling Prostaglandin 60 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 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 classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by lack of sterility assurance in a drug) fall under the Severe category.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling 5 vials of Prostaglandin 60 mcg/mL. The recall covers all lots of the product, which is distributed nationwide.
The recall was initiated because of a lack of sterility assurance. The source text does not specify the exact cause of the sterility issue or provide details on the manufacturing process failure.
Consumers who possess this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Prostaglandin 60 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 5
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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