Olympia Compounding Pharmacy recalls T-105 drug injection for potency issue
Olympia Compounding Pharmacy is recalling T-105, a compounded injectable drug containing papaverine, phentolamine, and PGE, due to a potency issue. The recall affects 1,093 vials distributed nationwide including Puerto Rico.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall initiated voluntarily by the firm due to a potency issue. The source text does not report any illnesses, injuries, or deaths. Class III recalls without reported harm are typically scored 1 or 2; the potency concern elevates this to Moderate (2) rather than Low.
Plain-English summary
Olympia Compounding Pharmacy is voluntarily recalling T-105, a multi-dose injectable drug containing papaverine 30 mg/mL, phentolamine 1 mg/mL, and PGE 10 mcg/mL. The product is packaged in 5 mL vials (NDC 73198-0005-05) and 10 mL vials (NDC 73198-0005-10), with lots E41F10 and E41G10 both expiring 5/10/22. The recall was initiated on March 8, 2022, and covers 1,093 vials.
The reason for the recall is that the product is super potent. The affected lots were distributed nationwide in the USA including Puerto Rico.
Consumers and healthcare providers who have this product should stop use and contact Olympia Compounding Pharmacy. Patients currently using this medication should consult their healthcare provider about appropriate next steps.
The recalled product
- Product
- T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL Multi-dose NDC 73198-0005-10; Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1%…
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 1,093
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)
- Lots: a) E41F10 Exp. 5/10/22
- b) E41G10 Exp. 5/10/22
Distribution
Part of a larger recall action
This product is one of 7 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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- High
- Moderate