Compounded injectable drug recall due to manufacturing quality control deviations
Olympia Compounding Pharmacy is recalling T-101, an injectable medication distributed nationwide, due to manufacturing quality control deviations in environmental and personnel monitoring prior to October 2021.
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: This is a risk-of-harm product (injectable from a compounding pharmacy with documented quality control deviations) where no illnesses or injuries have been reported. The manufacturing process deficiency in environmental monitoring creates potential for product contamination or sterility issues, but no confirmed harm has been documented. FDA Class II recalls without reported hospitalization typically score as High (3) when quality/safety processes failed.
Plain-English summary
Olympia Compounding Pharmacy is recalling T-101, an injectable medication containing Papaverine, Phentolamine, and Alprostadil, which was distributed nationwide across the United States.
The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. Specifically, prior to October 1, 2021, the pharmacy failed to properly investigate environmental and personnel monitoring excursions that exceeded acceptable limits. These monitoring systems are critical quality controls for ensuring the safety and sterility of injectable products.
The recall affects 2,437 vials distributed under five lot codes: E41B10 (BUD 5/10/2022), E41B08 (BUD 5/10/2022), I41C08 (BUD 9/8/2022), I41D08 (BUD 9/8/2022), and E41C10 (BUD 5/10/2022). Healthcare providers who dispensed this product should consult with Olympia Compounding Pharmacy or contact the FDA regarding their specific lot numbers and batch expiration dates to determine if they dispensed affected units.
The recalled product
- Product
- T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg/mL. Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0014-10; b) 5 mL Multi-Dose vial, NDC 73198-0014-05; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
- Category
- Drug — Compounded Injectable
- Affected units
- 2,437
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 (5)
- Lots: a) E41B10 BUD: 5/10/2022
- b) E41B08 BUD: 5/10/2022
- I41C08 BUD: 9/8/2022
- I41D08 BUD: 9/8/2022
- E41C10 BUD: 5/10/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 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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