Class II
Terminated
RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0016-10.
This recall has been terminated (originally issued May 4, 2022).
- Recall Initiated
- April 4, 2022
- Posted
- May 4, 2022
- Recall Number
- D-0814-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2201 vials
- Firm Location
- Orlando, FL, United States
- Official Source
- View on FDA website ↗
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
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lots: E42G11 BUD: 5/11/2022, H41003 BUD: 8/3/2022; H41B03 BUD: 8/3/2022
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