Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Zinc Sulfate 1 mg/mL MDV Injectable
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Zinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1418-10
Affected NDC
69699-1418-10
Compare with the code on your package — it is the most precise check available.
Drug: Zinc
- Recalling firm
- Pharm D Solutions, LLC
- NDC code
- 69699-1418-10
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0212-2019 · 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 Zinc recalls
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Class II · Moderate risk
Rohto Cooling Eye Drops ALL-IN-ONE
Lack of Assurance of Sterility
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Other recalls by Pharm D Solutions, LLC
All 2018 recalls
Class II · Moderate risk
Trimix 30mg/1 mg/10mcg/mL
Lack of Sterility Assurance.
Class II · Moderate risk
Testosterone Cypionate 200 mg/mL
Lack of Sterility Assurance.
Class II · Moderate risk
Testosterone Cyp/Pro 95/5%
Lack of Sterility Assurance.
Class II · Moderate risk
Testosterone 200 mg/mL
Lack of Sterility Assurance.
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