Prostaglandin E1 Injection Recalled Due to Sterility Assurance Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Prostaglandin E1 Injection Solution after FDA inspection found the products were manufactured in a manner that cannot guarantee sterility.
What this means for you
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: FDA Class II recall involving injectable drug with lack of sterility assurance. No illnesses or injuries have been reported. The hazard is serious—injectable medication contamination could cause infections—but the harm is theoretical without reported cases, warranting a High severity score.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Prostaglandin E1 Injection Solution 500MCG/ML, 1 mL vials (Rx only). The recall includes two specific lots: Lot 59993 (BUD 10/18/2022) and Lot 60932 (BUD 11/09/2022). The recalled product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
The recall was initiated after an FDA inspection determined that the recalled products were manufactured in a manner that cannot guarantee the sterility of the products. Prostaglandin E1 is an injectable medication, and lack of sterility assurance in injectable drugs poses a potential risk of serious infection to patients who received these products.
Patients who have received or possess this medication should contact their healthcare provider or pharmacy immediately. Healthcare providers should consult their pharmacy records to identify potentially affected patients and advise them not to use any remaining doses of this recalled medication.
The recalled product
- Product
- PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Injectable Solution
- Hazard
- lack-of-sterility
- contamination-risk
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)
- Lots: 59993 BUD: 10/18/2022
- 60932 BUD: 11/09/2022
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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