Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Labelling: Illegible label
Sterile Water for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Potential product carryover.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01
Affected NDC
0487-6105-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sterile Water NDC 00487-6105 |
WATER 1 mL/mL | Injection Intramuscular|intravenous|subcutaneous |
Nephron Pharmaceuticals Corporation | Rx |
- Recalling firm
- Nephron Sc Inc
- NDC code
- 0487-6105-01
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0364-2023 · 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 Nephron Sc Inc
All 2023 recalls
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Class II · Moderate risk
Sterile Water for Injection
CGMP Deviations: potential for trace amounts of product carryover.
Other cgmp deviation recalls from 2023
All cgmp deviation recalls
Class II · Moderate risk
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Class II · Moderate risk
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cGMP Deviations
Class III · Low risk
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Class II · Moderate risk
Strong Iodine Solution U.S.P.
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
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