Pharmacy Plus Injectable Drug Recall Due to Sterility Assurance Failure
Pharmacy Plus, Inc. recalled a compounded injectable medication (56 vials) due to manufacturing processes that cannot guarantee product sterility. 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: This FDA Class II recall involves compounded injectable medications with manufacturing processes that cannot assure sterility. The potential for microbial contamination of injectables presents a significant health risk despite no illnesses or injuries being reported to date.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 56 vials of PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN injectable solution (150MG / 2.5MG / 50MCG in 5mL vials). This is a prescription-only medication produced as a sterile compounded product.
FDA inspection revealed that the manufacturing process used to produce these vials does not provide adequate assurance that the final product is sterile, as claimed. Sterility is critical for injectable medications, as any microbial contamination could cause serious infection or other adverse health effects.
The recalled lots are Lot 64409 (beyond-use date 04/08/2023) and Lot 60849 (beyond-use date 05/23/2023). These products were distributed to healthcare facilities in Alabama, Louisiana, Mississippi, and Tennessee.
Healthcare providers who have received these vials should stop use immediately and contact their distributor or Pharmacy Plus, Inc. (located at 115 S. 40th Ave., Hattiesburg, MS 39402) for recall information and guidance on appropriate action.
The recalled product
- Product
- PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, 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-failure
- 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 (4)
- Lots: 64409
- BUD: 04/08/2023
- 60849
- BUD: 05/23/2023
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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