Buffered Penicillin G Potassium for Injection
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
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 (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04
Compare with the code on your package — it is the most precise check available.
Drug: Penicillin Category: Antibiotic
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 60793-0702 |
2400000 [iU]/4mL | 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.
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
cGMP Deviations: Products were stored outside the drug label specifications.
Lack of sterility assurance
Subpotent
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lack of Assurance of Sterility
Lack of Assurance of Sterility.
Lack of Assurance of Sterility.
Subpotent drug
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