University Compounding Pharmacy Recalls PGE-1 Injection Due to Sterility Concerns
University Compounding Pharmacy is voluntarily recalling PGE-1, 20 mcg/mL Injection in Normal Saline due to lack of assurance of sterility.
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 is classified as FDA Class II and involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
University Compounding Pharmacy is voluntarily recalling PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL. The recall is being conducted due to concerns regarding the lack of assurance of sterility for the product.
The affected product is identified by Lot # 497940 with an expiration date of 9/6/2013. The source text indicates that the product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact University Compounding Pharmacy at 855-398-1800 for further instructions or a refund.
The recalled product
- Product
- PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800.
- Manufacturer
- University Compounding Pharmacy
- Category
- Drug — Injectable Medication
- 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 (2)
- Lot #: 497940
- Exp 9/6/2013
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by University 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 5 products in this recall →Related recalls
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