Packaging & Labeling

EMA updates batch-number guidance for parallel-traded medicinal products

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EMA updated its GMP/GDP Q&A on 21 October 2026 concerning batch numbers on medicinal products relabelled or repacked for parallel trade. The Q&A states that applicable national legislation or guidance should be followed. Where none exists, the outer packaging should carry one batch number allocated by the parallel trader, ideally combining the original batch number with a unique repackaging or relabelling code. Traceability between original and additional numbers must be documented. If separate numbers are used, both must appear in recall information. A completely different parallel-trader batch number is strongly discouraged and requires justification and supervisory-authority authorisation.

Par Health Recalls 22 Argatroban Injection Lots for Particulate Matter

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Par Health USA announced a nationwide, hospital/user-level recall of 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) after particulate matter was detected in certain lots. Identified materials included cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. The affected lots were distributed to wholesalers and hospitals between December 30, 2024, and May 5, 2026. Par Health stated that administration of affected product could cause life-threatening vascular and inflammatory consequences. No related adverse events had been reported. Wholesalers and hospital pharmacies were instructed to discontinue use and distribution immediately and return existing inventory.

Par Health Recalls Two Dexmedetomidine Injection Lots for Particulate Matter

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Par Health announced a voluntary nationwide recall to the hospital level of two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 400 mcg/100 mL, after particulate matter was identified as cellulose or stopper material. The affected lots are 87558, expiring February 2027, and 88802, expiring April 2027. They were distributed to wholesalers between May 13 and June 29, 2025. Wholesalers and hospital pharmacies were instructed to stop use and distribution and return existing inventory. The announcement states that particulate administration could cause life-threatening vascular consequences. No related adverse events had been reported.

Otsuka ICU Medical Recalls Sodium Chloride Injection Lot for Potential Potassium Chloride Mix-Up

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Otsuka ICU Medical LLC announced a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, after a customer complaint identified a potential product mix-up. Sodium chloride overwraps from lot 1042188, NDC 0990-7984-23, may contain 10-mEq Potassium Chloride Injection bags from lot 1035181. The affected lot was manufactured on November 13, 2025, distributed in the United States from December 30, 2025, through June 22, 2026, and expires October 31, 2027. The company reported no related adverse events to date. Customers and distributors were instructed to inspect inventory, quarantine and discontinue use, and return affected product.

FDA Warning Letter: Unapproved Injectable Peptide Drugs Marketed by Royal Peptides

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FDA identified violations during a July 2026 review of Royal Peptides LLC’s website. FDA determined that products marketed as Tirzepatide, Semaglutide, Retatrutide, SS-31 (Elamipretide), PT-141, Tesamorelin, and BIMORELIN were drugs based on claims concerning metabolic regulation, weight loss, mitochondrial function, hormone modulation, recovery, and sexual dysfunction. FDA stated that these products were unapproved new drugs because they were not generally recognized as safe and effective for the labeled uses and had no approved applications in effect. Although product labeling included statements such as “for research use only” and “not for human or animal consumption,” FDA cited website evidence indicating intended human drug use. FDA also noted that the firm marketed bacteriostatic water with a peptide guide and calculator that collectively provided means to prepare an injectable drug for human administration. The letter does not describe a manufacturing-site inspection or identify specific CGMP, laboratory, validation, facility, or quality-system deficiencies.