Class I · High risk Ongoing
Glutathione
Reason Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
S-Ascorbic/Glutathione 1.25/1.25% Opth Soln
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX
- Recalling firm
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0200-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ascorbic recalls
See all
Class II · Moderate risk Ongoing
Ascorbic Acid
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ascorbic Acid
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
Ascorbic Acid Inj. Solution
Reason Presence of Particulate Matter: Presence of glass particulates.
Class III · Low risk Terminated
Peg-3350
Reason Defective container: potential for non-sealed pouches which can lead to product leakage.
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