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Recall Observatory FDA recall evidence

Drug 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

D-0722-2022

March 08, 2022

Class III

Product summary

Firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Event
Event 89717
Status
Terminated
Classification
Class III
Quantity
1032 vials
Official record key
drug-enforcement:D-0722-2022

Official wording

Reason: Sub Potent

Code information: Lots: a) E41C18 Exp. 5/18/22; b) E41D18 Exp. 5/18/22

Distribution pattern: Nationwide in the USA including Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sub Potent