Recalls / Class III
Class IIID-0722-2022
Product
SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 2% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, Conroy Rd., Ste. 155, Orlando, FL 32835
- Affected lot / code info
- Lots: a) E41C18 Exp. 5/18/22; b) E41D18 Exp. 5/18/22
Why it was recalled
Sub Potent
Recalling firm
- Firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6700 Conroy Rd Ste 155, N/A, Orlando, Florida 32835-3515
Distribution
- Quantity
- 1032 vials
- Distribution pattern
- Nationwide in the USA including Puerto Rico.
Timeline
- Recall initiated
- 2022-03-08
- FDA classified
- 2022-03-29
- Posted by FDA
- 2022-03-30
- Terminated
- 2023-10-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0722-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.