Injectable drug products need to have an extreme and successful sterile fill to finish. How do you ensure your manufacturers obtain the highest level of operational and quality excellence? Manufacturing environments must be tightly controlled—especially due to the increase in demand of sterile injectables. Qualifying every part of the product leading up to the final…
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Mylan Pharmaceuticals Inc. Conducting Voluntary Nationwide Recall of Insulin Injection
On April 12, 2022, Mylan Pharmaceuticals Inc. recalled one batch of insulin. Labels were missing on one batch of Insulin Glargine Injection. This package is an unbranded Insulin Glargine- yfgn vial and product information, batch number and expiry date information are present on the carton. Insulin Glargine was distributed in the United States between December…
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SYMJEPI Defect Recall
Imagine having an allergic reaction and the medication to save your life cannot be dispensed. SYMJEPI is an emergency treatment for patients who have an allergic reaction to something or anaphylaxis to stinging insects, allergen immunotherapy, foods, drugs, diagnostic testing substances and more. This injection is an emergency Epinephrine medication that is injected into patient…
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Overcoming the Challenges of Small Batch Production
Focusing on a targeted group of patients and trials has led to more small batch productions throughout the industry. These products are often expensive and very limited within the pharmaceutical industries. When having a limited amount of product for manufacturing, issues and rejects must be near zero. Although, product loss is unavoidable—most product loss is…
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