Sterile Talc Powder Recalled Due to Sterility Assurance Failure
Pharmacy Plus, Inc. is recalling sterile talc powder vials after FDA inspection found the manufacturing process cannot guarantee sterility. The product was 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 without reported illnesses or injuries. The hazard—inability to guarantee sterility of a pharmaceutical product—is a significant risk of harm, but no adverse events have been reported. This meets the rubric criterion for High (3): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling TALC, STERILE POWDER, 5 GM vials (Rx only) due to lack of assurance of sterility. An FDA inspection determined that the products were produced in a manner that cannot guarantee the sterility of the products purported to be sterile.
The affected lot is 65995 with a Beyond Use Date of 10/28/2022. Distribution was limited to Alabama, Louisiana, Mississippi, and Tennessee.
Consumers and healthcare providers who have received this product should not use it. Contact Pharmacy Plus, Inc. or your pharmacy for guidance on obtaining a replacement or alternative product. If you have questions, contact the recalling firm directly.
The recalled product
- Product
- TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug
- Hazard
- lack-of-sterility-assurance
- 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: 65995
- BUD: 10/28/2022
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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