FDAClass IIJune 1, 2022

NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 recall: Sterility Concern

NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155…

Why was NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 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?

Lot: L24C08 BUD: 12/8/2022

Product
NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155…
Recalling firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Quantity
606 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)
Open FDA enforcement record Latest recalls