RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL recall: Sterility Concern
RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Why was RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL recalled?
Lack of assurance of sterility.
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: K24B09, K24C09 BUD: 11/09/2022
- Product
- RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Quantity
- 1710 vials
- Distribution
- Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
- Recall date
- June 1, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)