Vasopressin
CGMP Deviations
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10
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 |
|---|---|---|---|---|
| Vasostrict Vasopressin NDC 42023-0237 |
, UNSPECIFIED .2 [USP'U]/mL | Injection Intravenous |
Par Health USA, LLC | 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
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.
Presence of Particulate Matter.
Crystallization; identified as Buprenorphine free base
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
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