CLASS II Drug recall · Reported 20 Feb 2019 · FDA Enforcement Report
Glycyrrhizic Acid, 8mg/mL Injection vial recalled by Promise Pharmacy
Promise Pharmacy is recalling Glycyrrhizic Acid, 8mg/mL Injection vial, distributed nationwide in the US. The recall was initiated on 17 Dec 2018 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes Lot: 11052018@6 BUD: 12/20/2018
Quantity recalled 2 10ml vials
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
Recall number D-0479-2019
FDA event ID 81810
Classification Class II
Status Terminated
Recall initiated 17 Dec 2018
FDA classified 8 Feb 2019
Reported 20 Feb 2019
Type Voluntary: Firm initiated
Customers notified by Letter
Timeline
17 Dec 2018 Recall initiated by company 8 Feb 2019 Classified by FDA +53 days 20 Feb 2019 Published in enforcement report +12 days
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it was distributed
Nationwide in the USA.
Nationwide
Questions about this recall
Why was it recalled? Lack of sterility assurance.
Which lots are affected? Lot: 11052018@6 BUD: 12/20/2018
Where was it sold? Nationwide in the USA.
What should I do if I have it? Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean? Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event 50 other products · FDA event 81810 This product is part of a recall event; the main page for the event is Acetylcysteine Ophthalmic Solution, 100mg/ml recalled .
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