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Recall Observatory FDA recall evidence

Drug 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

D-0720-2022

March 08, 2022

Class III

Product summary

Firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Event
Event 89717
Status
Terminated
Classification
Class III
Quantity
493 vials.
Official record key
drug-enforcement:D-0720-2022

Official wording

Reason: Sub Potent

Code information: Lot: D41C19 Exp. 4/19/22

Distribution pattern: Nationwide in the USA including Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sub Potent