Just within the last week, this publication has written about recalls from Sandoz, Janssen and three Canadian pharmaceutical firms due to API issues stemming from their Chinese manufacturer. Now three more companies have initiated voluntary recalls due to lapses in manufacturing quality.
Fresenius Kabi USA has recalled a single lot of magnesium sulphate Injection made at its Melrose Park, Illinois facility. “One of the 34 vials in reserve was observed with glass particulate matter,” Fresenius spokesperson Matthias Link told in-Pharmatechnologist.com, and “therefore a voluntary product recall was issued.”
So far, he continued, “there have been no reported adverse events, patient reactions or customer complaints associated with the recalled lot” and a root-cause investigation has been initiated at the site which is still underway.
Fresenius manufactures magnesium sulphate which is used in the treatment of magnesium deficiency, and as an anticonvulsant to prevent and control seizures in severe toxemia of pregnancy.
The drug is also on the US Food and Drug Administration’s (FDA) drug shortage list though Link told us the company does “not expect the recall to cause a supply disruption.”
J&J & Glenmark
Johnson & Johnson has recalled 19 lots of its formulation Tylenol from its Brazilian division.
According to foxbusiness.com, a detachment issue with the bottle meant there was a slim possibility that the dispenser may come loose from the bottle which could lead to accidental ingestion.
J&J’s subsidiary Janssen was forced to recall about 1.67m of its Children’s Tylenol Suspension recently at a facility in South Korea due to excessive levels of potentially liver-damaging acetaminophen.
The company has had several problems with Tylenol in recent years with musty odours coming from the bottles and inconsistencies in product label warnings leading to a number of recalls in the US.
And finally in this round-up, ‘musty odours’ have struck again but this time for Glenmark Generics who has initiated a recall of Gabapentin, Pravastatin Sodium and Topiramate Tablets from its Colvale, india facility after an “an off odor, described as moldy, musty or fishy in nature” was discovered, according to the FDA.
Neither J&J nor Glenmark responded to contact from in-Pharmatechnologist.com.