Dopamine HCl Inj.
Lack of Assurance of Sterility
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations; particulates identified during visual inspection
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| Bicillin L-A penicillin G benzathine NDC 60793-0701 |
1200000 [iU]/2mL | Injection, Suspension Intramuscular |
Pfizer Laboratories Div Pfizer Inc | 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.
Lack of Assurance of Sterility
Lack of Assurance of Sterility.
Lack of Assurance of Sterility.
Subpotent drug
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Presence of Particulate Matter: Hair was found in a prefilled syringe
Presence of Particulate Matter: Hair was found in a prefilled syringe
Presence of particulate matter - Glass like particles.
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