AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . recall: CGMP Deviations
AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155…
Why was AT-6, Papaverine 40mg/ml . Phentolamine 4mg/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: D41E20 BUD: 4/20/2022, D41F20 BUD: 4/20/2022, G41C13 BUD: 7/13/2022, G41B13 BUD: 7/13/2022
- Product
- AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155…
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Quantity
- 1318 vials
- Distribution
- Distributed Nationwide in the USA
- Recall date
- May 4, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)