Lidocaine/Phenylephrine Injectable Solution Recalled for Sterility Defect
Pharmacy Plus Inc.'s Lidocaine/Phenylephrine injectable solution is recalled due to manufacturing process deficiencies that cannot guarantee product sterility. The recall affects 389 syringes distributed in Alabama, Louisiana, Mississippi, and Tennessee.
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 of an injectable medication with manufacturing deficiencies preventing sterility assurance. No illnesses, injuries, or deaths reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in a High severity rating.
Plain-English summary
Pharmacy Plus, Inc. (doing business as Vital Care Compounder) is recalling Lidocaine/Phenylephrine PF Solution 1%/1.5% in 3 mL syringes. The affected lot is 65972, with a Beyond Use Date of October 27, 2022, and 389 syringes are involved.
The recall is due to a lack of assurance of sterility. During FDA inspection, the agency determined that the recalled products were produced in a manner that cannot guarantee the sterility required for injectable products.
The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee. This recall affects any remaining product from the specified lot that may be in use or in inventory.
Patients and healthcare providers who have this product should be aware of the recall. Contact with a healthcare provider may be appropriate for those who have received doses from this affected lot.
The recalled product
- Product
- LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-defect
- 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)
- Lot: 65972
- BUD: 10/27/2022
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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