QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . recall: CGMP Deviations
QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only Olympia Pharmaceuticals…
Why was QM-2 Papaverine 30 mg/mL. Phentolamine 3 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: D41219 BUD: 4/19/2022, I24C13 BUD: 9/13/2022
- Product
- QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only Olympia Pharmaceuticals…
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Quantity
- 1871 vials
- Distribution
- Distributed Nationwide in the USA
- Recall date
- May 4, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)