NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10
Reported: May 4, 2022 Initiated: April 4, 2022 #D-0803-2022
Product Description
NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10
Reason for Recall
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Details
- Recalling Firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Units Affected
- 3509 vials
- Distribution
- Distributed Nationwide in the USA
- Location
- Orlando, FL
Frequently Asked Questions
What product was recalled? ▼
NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10. Recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy. Units affected: 3509 vials.
Why was this product recalled? ▼
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 4, 2022. Severity: Moderate. Recall number: D-0803-2022.
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