June 28, 2011: McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling at the retail level one product lot (60,912 bottles) of TYLENOL®, Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recalled product was manufactured in February, 2009. McNeil is taking this action following a small number of odor reports, including musty, moldy odor. The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).
This voluntary action is being taken as a precaution and the risk of serious adverse medical events is remote. TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms.
The product lot number for the recalled product can be found on the side of the bottle label.
FULL RECALLED PRODUCT LIST:
TYLENOL®, Extra Strength Caplets, 225 countABA619300450444271
McNeil-PPC recommends the following:
- Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time) for instructions about receiving a refund or product coupon.
- Consumers who have medical concerns or questions should contact their healthcare provider.
- Any adverse reactions may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax
June 24, 2011: Qualitest Pharmaceuticals today issued a voluntary nationwide retail level recall of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, and Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg. This recall was initiated because an individual bottle of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, 500 count was found incorrectly labeled with a Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg, 1000 count label, printed with Lot Number C0590909B. Lots C0390909A, C0400909A, C0410909A used the same stock inventory of labels as Lot C0590909B and are potentially impacted.
Because the recalled bottles may contain incorrect tablets, patients may unintentionally take butalbital and caffeine instead of hydrocodone (Acetaminophen is in both preparations.) 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.
The recall includes the following products:
- Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, NDC 0603-2544-28 500 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B
- Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg / 500mg, NDC 0603-3882-32, 1000 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B
This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration. These lots were distributed between November 13, 2009 and April 9, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico). Lot numbers can be found on the side of the manufacturer’s bottle. Butalbital, Acetaminophen, and Caffeine Tablets are (approximately 11.0 mm in diameter), white round-shaped tablets, debossed (2544) on one side, and debossed (V) on the reverse side; Hydrocodone Bitartrate and Acetaminophen Tablets are (approximately 16.5 mm in length), white with green specs, round, capsule shaped, scored tablets, debossed (3594) and (V) on one side and plain on the reverse side. All patients who have filled prescriptions of Hydrocodone Bitartrate and Acetaninophen manufactured by Qualitest, are asked to double check the identity of their tablets.
Tablet descriptions:
- Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg are supplied as white with green specks, capsule-shaped, scored tablets, debossed “3594” on one side and debossed “V” on the reverse side.
- Butalbital, Acetaminophen and Caffeine Tablets, USP
Containing 50 mg butalbital, 325 mg acetaminophen and 40 mg caffeine. Available as white, round shaped tablets, debossed “2355” on one side, and debossed “V” on the reverse side.
Qualitest recommends the following:
- Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product.
- Consumers and patients with questions may contact Qualitest at 1-800-444-4011 for more information. Monday through Friday between the hours of 8AM and 5PM CST.
- Adverse reactions or quality problems experienced with the use of this product may be reported to the manufacturer or to FDA’s MedWatch Adverse Event Reporting program either on line, by regular mail, or by fax.
June 24, 2011: Endo Pharmaceuticals today issued a voluntary nationwide consumer level recall of Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV and #402426NV. One bottle from each lot of Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg, Lot # 402415NV and # 402426NV, NDC 60951-712-70, 100 count bottles, was found to contain some Endocet® 10 mg/650 mg Tablets, which are identifiable by their larger size, and different shape and markings. Currently, no other bottles from the subject lots or any other lots have been found to erroneously contain Endocet® 10 mg/650 mg Tablets. No injuries have been reported to date.
Because the recalled bottles may contain incorrect tablets that have a higher dosage of acetaminophen, consumers may take more than the intended acetaminophen dose. 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. The product label warns consumers that acetaminophen overdosage can potentially cause severe liver damage.
Endo Pharmaceuticals recommends the following:
- Consumers who have the affected product should stop using the product and contact Endo’s agent Stericycle at 1-866-723-2681 for return of the product. If consumers have any questions as to whether they possess the affected product, please call the number listed above.
The recall includes the following lots of this product:
- Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg /325 mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV, Expiry 01/2014; and
- Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg /325 mg 100 count bottles, NDC 60951-712-70,Lot # 402426NV, Expiry 01/2014
This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.
These lots were distributed between April 19, 2011 and May 10, 2011 directly to wholesalers who are located in the following states: AL, AZ, CA, CO, NY, OH, ND, PR, IL, KY, NH, NJ, LA, NC, MO, PA, FL and TN. These wholesalers may further distribute to other retailers and wholesalers nationwide. Lot numbers can be found on the side of the manufacturer’s bottle.
June 17, 2011: Ortho-McNeil-Janssen Pharmaceuticals, Inc. is initiating a voluntary recall of one lot of RISPERDAL® (risperidone) 3mg Tablets, marketed by Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and one lot of risperidone 2mg Tablets, marketed by Patriot Pharmaceuticals, LLC, a wholly owned subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc. The recalls stem from two consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole). TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which materials are transported and stored. In January 2010, the company instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to certify that they do not use pallets made from chemically-treated wood.
While not considered to be toxic, TBA can generate an offensive odor and a very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odor. As it relates to RISPERDAL® and risperidone, there have been no reported serious adverse events caused by the presence of TBA.
The RISPERDAL® lot - which includes approximately 16,000 bottles - was shipped between 8/27/2010 and 2/15/2011. The company believes there are approximately 1,600 bottles of RISPERDAL® from this lot remaining in the marketplace. The risperidone lot - which includes approximately 24,000 bottles - was shipped between 11/10/2010 and 1/01/2011. The company believes there are fewer than 1,200 bottles of risperidone from this lot remaining in the marketplace.
RISPERDAL® (risperidone) Tablets
3mg Bottles of 60 Tablets50458-330-060GG904May 2012Risperidone Tablets
2mg Bottles of 60 Tablets50458-593-600LG175August 2012
RISPERDAL® (risperidone) is used for the treatment of schizophrenia in adults and adolescents ages 13-17 years.
RISPERDAL® (risperidone) is used alone or in combination with other medicines (valproate or lithium) in adults for the short-term treatment of bipolar mania; or alone in adults, children and adolescents ages 10-17 years for the short-term treatment of bipolar mania. RISPERDAL® (risperidone) is used for the treatment of irritability associated with autistic disorder in children and adolescents ages 5-16 years.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. has initiated these recalls in the U.S. and Puerto Rico at the wholesale and retail (pharmacy) level and is communicating this information to these customers. The company does not anticipate a product shortage resulting from this action.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. recommends the following:
Patients should not stop taking their medication.
Anyone experiencing an uncharacteristic odor associated with RISPERDAL® 3mg Tablets or risperidone 2mg Tablets should return the tablets to their pharmacist, and contact their healthcare professional if they have questions.
