Recalls Issued for Oxycodone, Hydrocodone and Butalbital

Karen Lee Richards Health Guide June 27, 2011
  • Voluntary recalls were issued for specific lots of two opioid pain relievers and one medication for tension headaches.  The affected drugs include:

    • Endocet (oxycodone/acetaminophen), 10/325 mg
    • Hydrocodone/acetaminophen, 7.5/500 mg
    • Butalbital/acetaminophen/caffeine, 50/325/40 mg

    Endocet (oxycodone/acetaminophen)

    Endo Pharmaceuticals issued the nationwide Endocet recall because a bottle from each of two lots was found to contain some 10/650 mg tablets, which is twice the dosage of acetaminophen on the label. Because of this, consumers may take more than the intended acetaminophen dose. 

    Possible Dangers:  Unintentional administration of tablets with increased acetaminophen content may result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. 


    Lots:  The two lots affected are Lot # 402415NV and Lot # 402426NV.  They were distributed to wholesalers between April 19, 2011 and May 10, 2011. 

    Tablet Descriptions:  Endocet 10 mg/325 mg tablets are 0.6 inches in length, 0.27 inches in width and yellow capsule-shaped tablets, marked “E712” on one side and “10/325” on the other.  By contrast, Endocet® (oxycodone/acetaminophen, USP) 10 mg/650 mg tablets are larger (0.7 inches in length, 0.4 inches in width) and yellow oval-shaped tablets, marked “E797” on one side and “10”on the other.

    What to do:  If you think you may have received some of the affected Endocet, you can contact Endo’s agent Stericycle at 1-866-723-2681 during the hours of 8AM – 8PM EST Monday through Friday and 8AM – 5PM EST Saturday and Sunday.

    Hydrocodone/Acetaminophen and Butalbital/Acetaminophen/cCaffeine

    Qualitest Pharmaceuticals issued a recall of four lots of hydrocodone/acetaminophen, 7.5/500 mg and four lots of butalbital/acetaminophen/caffeine, 50/325/40 mg because the labels for the two drugs may have been switched with one another. 

    Possible Dangers:  Unintentional administration of butalbital could result in symptoms such as sedation, lightheadedness, dizziness, and nausea. Additionally, patients with an allergy to butalbital could experience a hypersensitivity reaction. 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. Patients who were receiving hydrocodone for chronic pain might experience worsening pain and withdrawal symptoms as a result of this substitution. No injuries have been reported to date.

    Lots:  The lots affected are Lot numbers C0390909A, C0400909A, C0410909A, and C0590909B.  These lots were distributed between November 13, 2009 and April 9, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico).

    Tablet descriptions:

    Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5/500 mg are white with green specks, capsule-shaped, scored tablets, marked “3594” on one side and “V” on the reverse side.


  • Butalbital, Acetaminophen and Caffeine Tablets, 50/325/40 mg are white, round-shaped tablets, marked “2355” on one side, and “V” on the reverse side.


    What to do:  Consumers and patients with questions may contact Qualitest at 1-800-444-4011 for more information on Monday through Friday between the hours of 8AM and 5PM CST.

    Sources:
    FDA Press Release (June 24, 2011). Endo Pharmaceuticals Issues Voluntary, Nationwide Recall of Two Lots of Endocet® (Oxycodone/Acetaminophen, USP) Tablets, 10 MG / 325 MG.

    FDA Press Release (June 24, 2011). Qualitest Pharmaceuticals Issues Voluntary, Nationwide Retail Level Recall of Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets, USP 50mg/325mg/40mg and Four Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg