Prescription Injectable Medication Recalled for Sterility Assurance Failure
Pharmacy Plus, Inc. recalled a prescription injectable medication (Papaverine/Phentolamine/Prostaglandin) because FDA inspection found the product was produced in a manner that cannot guarantee sterility. Lot 65976 (BUD 10/27/2022) was distributed in AL, LA, MS, and TN.
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: This is an FDA Class II recall for a prescription injectable medication with lack of sterility assurance. The hazard is theoretical with no reported illnesses or injuries, meeting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder has recalled a prescription injectable medication containing Papaverine 150mg, Phentolamine 5mg, and Prostaglandin 10mcg per 5 mL vial. The product is manufactured by Pharmacy Plus, Inc. at 115 S. 40th Ave., Hattiesburg, MS 39402.
The recall was initiated following an FDA inspection that determined the product was produced in a manner that cannot guarantee the sterility of the product. Injectable medications require sterility to ensure patient safety and prevent infection.
Lot number 65976 with a beyond-use date of October 27, 2022, was distributed in Alabama, Louisiana, Mississippi, and Tennessee. Healthcare providers and patients should consult with Pharmacy Plus, Inc. or their healthcare provider regarding this medication.
The recalled product
- Product
- PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Injectable Medication
- Affected units
- 1
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: 65976
- BUD: 10/27/2022
Distribution
Part of a larger recall action
This product is one of 32 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder 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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