Vasopressin
CGMP Deviations
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations
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.
Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12.
Compare with the code on your package — it is the most precise check available.
Drug: Vasopressin
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 |
|---|---|---|---|---|
| Vasopressin in 0.9% Sodium Chloride NDC 00338-9647 |
VASOPRESSIN 40 [USP'U]/100mL | Injection Intravenous |
Baxter Healthcare Corporation | Rx |
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.
CGMP Deviations
Subpotent Drug
Subpotent product in addition to having out-of-specification results for impurities.
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Subpotent Drug
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Presence of particulate matter: Particulates identified as fiberglass
CGMP Deviations
CGMP Deviations
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