A potential packaging glitch that could compromise sterility has triggered a recall at Sagent Pharmaceuticals.
The drugmaker issued a voluntary recall of three lots of injectable phenylephrine hydrochloride, which is used to treat low blood pressure during anesthesia.
The recall stemmed from a customer complaint of loose crimped vial overseals, which could result in a non-sterile product. Contamination of the IV drug could cause potentially fatal systemic infections, the company said in a recall announcement posted by the FDA on Thursday.
The possibility of a breach in sterility of the product, while remote, cannot be eliminated, the recall notice said. No adverse events associated with the issue have been reported to Sagent.
The recalled product was manufactured by Indoco Remedies of India and distributed by Sagent, a Chicago-based subsidiary of Nichi-Iko Pharmaceutical of Japan, which specializes in sterile injectables.
Sagent had two antibiotic recalls in 2016 over sterility issues. Two years later, the company recalled 10 lots of methylprednisolone sodium succinate after detecting a higher-than-permitted level of impurities. And two years ago, Sagent recalled one lot of Ketorolac Tromethamine Injection due to a microbial growth detected during simulation of the manufacturing process.
The recall is to the user level. The three lots were distributed between Nov. 17, 2020 and March 8, 2021, with expiration dates of August and September of 2022.
Customers are being notified of the recall and are instructed to stop use of the product and return any that is unused. Those who redistributed the product must identify customers and notify them of the recall.