Drugmakers Sun Pharma, Cipla, Zydus and Graviti Pharmaceuticals are recalling different products in the U.S., most of them over manufacturing issues, according to latest U.S FDA enforcement reports.
Sun Pharma is recalling 24,624 Fluocinolone Acetonide topical solution 60-mL bottles distributed by Taro Pharmaceuticals Inc. after out of specification result was obtained for a known impurity. It has also initiated recall of acne drug Clindamycin Phosphate topical solution 60 mL bottle manufactured by Taro Pharmaceutical Industries on account of out of specification results for total impurities and for assay.
Cipla is recalling more than 15,000 syringes of Lanreotide Injection 120 mg/0.5 mL, which is used to treat a rare horomonal condition, manufactured for Cipla USA, Inc. Earlier this month, it said Greek firm Pharmathen is the manufacturer and exclusive supplier of Lanreotide Injection to its U.S. subsidiary and the product is among its top three products in the US market.
Production of Lanreotide has been temporarily paused to support remediation efforts in the wake of U.S. FDA inspection and issue of nine observations to Pharmathen’s facility in Greece. Until manufacturing resumes, the product will remain in limited supply, subject to quality clearance.
Cipla is recalling 92,376 tubes of Diclofenac Sodium Topical Gel 100 g manufactured by DPT Laboratories for failed PH specifications.
Hyderabad-based Graviti Pharmaceuticals is recalling 4,212 bottles of Furosemide Tablets, (USP 40 mg, 1,000 Tablets) manufactured for Rising Pharmaceuticals Inc for presence of foreign substance.
Zydus Pharmaceuticals (USA) is recalling 22,896 bottles of Icosapent Ethyl capsules, 1 gram (120-count bottles) manufactured by Softgel Healthcare due to oxidation caused by leakage of the contents of the capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.
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