SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Reported: June 1, 2022 Initiated: May 9, 2022 #D-0901-2022
Product Description
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Reason for Recall
Lack of assurance of sterility.
Details
- Recalling Firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Units Affected
- 874 vials
- Distribution
- Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
- Location
- Orlando, FL
Frequently Asked Questions
What product was recalled? ▼
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. Recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy. Units affected: 874 vials.
Why was this product recalled? ▼
Lack of assurance of sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 1, 2022. Severity: Moderate. Recall number: D-0901-2022.
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