Recalls / Class III
Class IIID-0720-2022
Product
Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0004-10
- Affected lot / code info
- Lot: D41C19 Exp. 4/19/22
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
- 493 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-0720-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.