Recall report: Acella pulls thyroid tablets after a raft of side effect reports; mislabeling causes Pfizer's Hospira to yank 2 lots of anesthetics
Acella Pharmaceuticals has pulled its NP Thyroid tablets off US shelves after routine testing found different versions of the drug not hitting potency marks. In this case, that screw-up had an immediate effect on patients with 43 reports of serious side effects, the FDA said.
The 38 recalled lots contained less than 90% of their labeled amount of liothyronine and levothyroxine, the FDA said. Of those lots, 35 of them were 100-count bottles of either 15mg, 120mg, 30mg, 60mg or 90 mg tablets. Another three were seven-count bottles of 15mg, 30mg and 120mg tablets.
Patients who take the hypothyroidism medication could experience signs of an underactive thyroid, which includes fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression and unexplained weight loss or game. There is reasonable risk of serious injury in newborn infants or pregnant women as well, including early miscarriage or neural and skeletal development impairments. Elderly patients may experience cardiac pain, heart palpitations or cardiac arrhythmia.
“Acella is proactively notifying its consignees to discontinue distribution of the above referenced lots being recalled and is arranging for return of all recalled products,” the FDA said. “Patients who are currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance or a replacement prescription.”
Pfizer’s Hospira is also recalling two lots of anesthetics — one of bupivacaine hydrochloride injection and one of lidocaine hydrochloride injection — after switching up the labels on both products.
The issue was identified as an investigation of a customer report, the FDA said this week.
If the 0.5% bupivacaine were to be administered to a patient instead of the necessary 1% lidocaine, an overdose is possible, which could lead to seizures, respiratory and heart abnormalities. If the 1% lidocaine was administered instead of the dose of bupivacaine, a patient could be severely underdosed and the drug would not provide adequate pain management, Hospira said.
“To date, Hospira has not received reports of any adverse events associated with this issue for these lots,” the FDA said.
The two lots, EG6023 for the bupivacaine and EG8933 for the lidocaine, were set to expire on July 1, 2022, and Aug. 1, 2022, respectively, and distributed between Dec. 29, 2020, to April 15, 2021.
Form 483s from FDA inspections at Hospira’s plant found a number of problems with that plant’s operations, including inadequate and incomplete impact and risk assessments and inadequately qualified monitoring of the manufacturing process. Procedures to prevent microbiological contamination of drug products were also not established, the forms stated.