Papaverine HCL Stock Solution Recalled Due to Sterility Assurance Failure
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Papaverine HCL Stock Solution 30mg/ml vials due to lack of sterility assurance. FDA inspection found the product was produced in a manner that cannot guarantee 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: This is an FDA Class II recall for lack of sterility assurance in an injectable product. While no illnesses or injuries have been reported, the loss of sterility assurance in an injectable medication presents a risk of serious infection to patients. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported,' warranting a High severity score.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Papaverine HCL Stock Solution 30mg/ml, 10 mL vials due to lack of assurance of sterility. FDA inspection found that the products were produced in a manner that cannot guarantee the sterility of the products purported to be sterile.
The recalled product carries Lot Number 60552 and has a Beyond Use Date of 03/12/2023. It was distributed in Alabama, Louisiana, Mississippi, and Tennessee, affecting 28 vials.
The recalled vials should not be used. Persons who have received or used this product should contact their healthcare provider to discuss any potential risks and necessary follow-up care.
The recalled product
- Product
- PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 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 Pharmaceutical
- Affected units
- 28
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: 60552
- BUD: 03/12/2023
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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