Pregabalin 75mg capsules were labelled as 25mg strength on one section of the foil blister pack in a batch first distributed in mid-June.
About a third of blister packs from the batch were incorrectly labelled, but the strength is correct on carton labels and in patient information leaflets. Teva said it is not recalling the affected stock “to ensure continuity of supply,” but it will not put any more of the mislabelled drug on the market.
Pfizer
Pfizer’s eye drug Xalatan (latanoprost) has seen increased reporting of eye irritation since it was reformulated. The company reduced the product’s pH from 6.7 to 6.0 to allow long-term storage at room temperature. MHRA said it received no Yellow Card reports of eye irritation from European Xalatan patients in the year before reformulation, compared with 22 reports the year after.
Pfizer is not recalling the drug, but MHRA advised doctors to report suspected side effects on a Yellow Card and review treatment if patients mention irritation.
Hartley Medical
A compounding pharmacy in Long Beach, California has recalled three lots of an injectable because of sterility concerns. The affected 5ml and 100ml vials of Prolotherapy with Phenol for treating neurolysis were distributed in California and Nevada to pain clinics between May and July this year.
Hartley Medical said it has not received any reports of product contamination or adverse events related to the batches, but it issued a recall following a recent inspection that uncovered problems with sterility and testing procedures at the manufacturing site.