Injectable hormone medication recalled for sterility assurance failure
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Medroxyprogesterone Acetate 300 mg/mL suspension due to lack of sterility assurance. The product was produced in a manner that cannot guarantee sterility of the injectable medication.
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 of an injectable medication where sterility assurance cannot be guaranteed. No illnesses or injuries have been reported. The product qualifies as a risk-of-harm item (non-sterile injections can cause serious infection), but the absence of reported adverse events and Class II classification support High rather than Severe.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Medroxyprogesterone Acetate 300 mg/mL suspension (lot 55786) following an FDA inspection. The inspection determined the product was manufactured in a manner that cannot guarantee the sterility of this injectable medication.
Medroxyprogesterone acetate is an injectable pharmaceutical product that must be sterile. The inability to assure sterility creates a potential risk of infection from the injection.
The recalled product was distributed in Alabama, Louisiana, Mississippi, and Tennessee. The affected lot number is 55786, with a beyond-use date of December 31, 2022.
Consumers who have this medication should contact their healthcare provider to discuss whether they received a potentially affected lot and what steps to take.
The recalled product
- Product
- MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 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 / Hormone
- Hazard
- sterility-failure
- infection-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: 55786
- BUD: 12/31/2022
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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