FDA Recalls Phenylephrine 1 mg/mL Vials for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling 9,102 vials of Phenylephrine 1 mg/mL due to lack of assurance of sterility. The affected vials were distributed nationwide in the United States, Puerto Rico, and US Virgin Islands.
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 injectable drug with potential for serious infection due to sterility assurance failure, though no illnesses have been reported. Meets the rubric criterion: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Olympia Compounding Pharmacy dba Olympia Pharmaceuticals is recalling 9,102 multi-dose vials of Phenylephrine 1 mg/mL (NDC 73198-0021-05) due to lack of assurance of sterility.
The recalled product includes two lots: K41016 with a beyond-use date of 11/16/2022, and A24025-22 with a beyond-use date of 1/25/2023. These vials were distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands.
Customers who have received these recalled vials should contact Olympia Compounding Pharmacy or their healthcare provider for guidance. Any adverse events related to use of the recalled product should be reported to the FDA.
The recalled product
- Product
- Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0021-05.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug
- Hazard
- sterility-failure
- contamination
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 (1)
- Lots: K41016 BUD: 11/16/2022 and A24025-22 BUD: 1/25/2023
Distribution
Distributed nationwide across the United States.
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