

RECOMMENDATION : Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product. Tablet descriptions and photographs of tablets for these two products are provided in the firm's press release. Lot numbers can be found on the side of the manufacturer’s bottle. These lots were distributed between Novemand Apto wholesale and retail pharmacies nationwide (including Puerto Rico). Patients who were receiving hydrocodone for chronic pain might experience worsening pain and withdrawal symptoms as a result of this substitution.īACKGROUND : The recall includes the following products: Side effects due to caffeine are less likely, due to the small amounts in this formulation, however, those individuals with a sensitivity to caffeine may experience symptoms such as tremors, irritability, and difficulty sleeping. Additionally, patients with an allergy to butalbital could experience a hypersensitivity reaction. Unintentional administration of butalbital could result in symptoms such as sedation, lightheadedness, dizziness, and nausea.
Butalbital acetaminophen caffeine professional#
Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.ISSUE : Qualitest and FDA is notifying pharmacists and patients of a recall to the retail level of specific lots of Butalbital, Acetaminophen, and Caffeine Tablets and Hydrocodone Bitartrate and Acetaminophen Tablets due to possibility that the recalled bottles may contain incorrect tablets, and patients may unintentionally take butalbital and caffeine instead of hydrocodone.Caution patient to avoid concurrent use of alcohol or other CNS depressants.Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.Advise patient to avoid driving and other activities requiring alertness until response to medication is known. Medications taken for prophylaxis should be continued. Lying down in a quiet, dark room may also be helpful.


Additive CNS depression with other CNS depressants, including alcohol, antihistamines, antidepressants, opioid analgesics, and sedative/hypnotics.
