Class II · Moderate risk
Zinc Sulfate 1mg/Ml Injection Solution
Lack of Assurance of Sterility
Ascorbic Acid 400 MG/ML
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Crystallization
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Ascorbic Acid 400 MG/ML (Non-Corn) Injection Solution, 65 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0914-65
Affected NDC
70731-0914-65
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- RXQ Compounding LLC
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1635-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by RXQ Compounding LLC
All 2019 recalls
Class II · Moderate risk
Zinc Sulfate 1mg/Ml Injection Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin B Complex 100
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin B Complex 100
Lack of Assurance of Sterility
Other failed specification recalls from 2019
All failed specification recalls
Class II · Moderate risk
Blisovi Fe 1.5/30
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Class II · Moderate risk
Vancomycin Hydrochloride for Injection
Discoloration: Product complaints of discoloration after reconstitution of vials.
Class II · Moderate risk
Fluphenazine Decanoate Injection USP 125mg/5mL
Discoloration; Hazy solution found in one vial instead of a clear solution.
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