Dexpanthenol 250 mg/mL Injectable Solution Recalled for Sterility Failure
Olympia Compounding Pharmacy is recalling 1,296 vials of Dexpanthenol 250 mg/mL injectable solution distributed nationwide due to lack of assurance of sterility in the manufacturing process.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 lack of sterility assurance. Per the rubric criterion for risk-of-harm products where injury has not yet been reported, this warrants a High severity rating.
Plain-English summary
Olympia Compounding Pharmacy is recalling 1,296 vials of Dexpanthenol 250 mg/mL multi-dose injectable solution (NDC 73198-0070-30, Lot L24016, BUD 6/16/2022) distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands.
The recall was initiated due to lack of assurance of sterility in the manufacturing process. Dexpanthenol is an injectable medication, and sterility is critical for injectable products to prevent contamination and potential infections when administered to patients.
Healthcare providers and patients affected by this recall should consult with their healthcare provider regarding any concerns. Healthcare providers should verify whether they have received or dispensed this product and take appropriate precautions for patients who may have received the medication.
The recalled product
- Product
- Dexpanthenol 250 mg/mL Multi-Dose 30 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0070-30
- Affected units
- 1,296
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)
- Lot: L24016 BUD: 6/16/2022
Distribution
Part of a larger recall action
This product is one of 53 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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