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Pakistan Drug Authority Orders Immediate Recall of Contaminated Metronidazole Infusion Over Bacterial Endotoxin Contamination

Drug Recall
  • Pakistan's Drug Regulatory Authority ordered the immediate withdrawal of Anarob Infusion batch H24219 after laboratory testing revealed dangerous levels of bacterial endotoxins exceeding safety specifications.
  • The contaminated metronidazole infusion poses severe health risks including fever, chills, septic shock, and life-threatening complications, particularly for hospitalized and immunocompromised patients.
  • Healthcare facilities and pharmacies have been directed to immediately quarantine remaining stocks and conduct comprehensive market surveillance to ensure complete removal of the defective antibiotic product.

FDA Issues Warning Letter to Glenmark Pharmaceuticals Following Manufacturing Quality Violations

Drug Recall
  • The FDA issued a warning letter to Glenmark Pharmaceuticals citing serious manufacturing violations at its Madhya Pradesh factory, including delayed safety testing that contributed to recalls of potentially deadly medications.
  • More than 50 million potassium chloride extended-release capsules were recalled due to dissolution problems that could cause fatal cardiac events, with eight deaths reported to the FDA between July and December 2023.
  • The warning letter highlighted systematic failures across multiple Glenmark manufacturing sites, with three of five factories producing drugs for the U.S. market having regulatory violations since 2019.
  • FDA inspectors found that Glenmark's safety testing was overdue by three months or longer for a large proportion of samples, with some potassium chloride tests taking 100 days to complete.

Nostrum Laboratories Recalls Sucralfate Tablets Following Bankruptcy and Operational Shutdown

Drug Recall
  • Nostrum Laboratories Inc. has voluntarily recalled all lots of Sucralfate Tablets USP 1 gram manufactured after June 2023 following the company's Chapter 11 bankruptcy filing and operational shutdown.
  • The recall was initiated because the discontinuation of quality control activities means the company cannot assure the product meets identity, strength, quality, and purity specifications.
  • All recalled lots should be destroyed immediately as the company is not accepting returns, and consumers experiencing problems should contact their healthcare providers.
  • The medication, used to treat ulcers, was distributed to wholesalers, retailers, manufacturers, medical facilities, and repackagers nationwide.

UK Issues Class 2 Recall for Zaditen Eye Drops Batch Due to Potential Microbial Contamination Risk

Drug Recall
  • The UK's MHRA has issued a class 2 medicines recall for batch 4V64 of Zaditen 0.25 mg/ml eye drops solution due to a manufacturing event that may increase microbial contamination risk.
  • Approximately 11,360 packs of the affected batch were distributed starting January 27, 2025, with an expiration date of September 30, 2026.
  • Healthcare professionals must immediately stop supplying the batch and quarantine all remaining stock for return to suppliers.
  • No adverse events or product quality complaints have been reported to date, and the recall is being conducted as a precautionary measure.

Aurobindo Pharma Recalls Over 4,600 Bottles of Acetaminophen in US Due to Tablet Discoloration

Drug Recall
  • Aurobindo Pharma's US unit is recalling 4,608 bottles of Acetaminophen Tablets (325 mg) due to manufacturing deviations and confirmed consumer complaints about tablet discoloration.
  • The recall was classified as Class II by the FDA, indicating potential temporary or medically reversible health consequences with minimal likelihood of serious adverse outcomes.
  • The affected pain relief medication is commonly used to treat headaches, migraines, toothaches, back pain, and muscle pain.
  • The recall was initiated on May 22 following observations of brown surface discoloration on tablets, representing a violation of Current Good Manufacturing Practices.

FDA Recalls Nearly 76,000 Cases of Eye Care Products Due to Manufacturing Deviations

Drug Recall
  • The FDA has issued a recall for approximately 76,000 cases of over-the-counter ophthalmic products following an audit that revealed significant manufacturing deviations at BRS Analytical Services.
  • Five different eye care products are affected, including artificial tears and lubricant eye drops, distributed nationwide between May 2023 and April 2025, with expiration dates ranging through March 2027.
  • The recall stems from concerns about "lack of assurance of sterility," which could potentially compromise product safety, though the specific health hazards remain unknown.

FDA Recalls Six Acne Products After Testing Reveals Benzene Contamination Above Safety Limits

Drug Recall
  • The FDA announced voluntary recalls of six popular acne products containing benzoyl peroxide after testing revealed elevated benzene levels above the conditional limit of two parts per million.
  • Independent testing by Valisure laboratory found that benzoyl peroxide breaks down into the carcinogen benzene over time, with some products containing levels as high as 35 ppm.
  • Of 95 acne products tested by the FDA, more than 90 percent had undetectable or extremely low benzene levels, but six products required recall due to elevated contamination.
  • Researchers emphasize that benzene exposure from multiple sources creates cumulative cancer risk, particularly concerning for products applied directly to skin.

FDA Recalls 7,107 Bottles of Generic Duloxetine Over Carcinogenic Chemical Contamination

Drug Recall
  • The FDA issued a Class II recall for 7,107 bottles of generic duloxetine antidepressant due to contamination with N-nitroso-duloxetine, a toxic chemical suspected of causing cancer.
  • The recalled medication was manufactured by Towa Pharmaceutical Europe and distributed nationally, affecting 500-count delayed-release 20mg capsules with lot number 220128 and December 2024 expiration.
  • Patients are advised not to stop taking their medication abruptly but should consult healthcare professionals about the best course of action for their treatment.
  • The recall reflects increased FDA testing for nitrosamine impurities in medications, with the agency working internationally to establish safer daily intake limits for these chemicals.

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