T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL recall: CGMP Deviations
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.
Why was T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL recalled?
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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.
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Quantity
- 2437 vials
- Distribution
- Distributed Nationwide in the USA
- Recall date
- May 4, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)