Contact:Consumer: 1-800-444-4011
Media: Blaine Davis 1-610- 459-7158
FOR IMMEDIATE RELEASE December 6, 2012 Qualitest, a subsidiary of Endo Health Solutions, (Nasdaq: ENDP) today issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. This includes product with the following NDC numbers and lot numbers beginning with the letter C.
It is possible that a number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients of hydrocodone bitartrate and acetaminophen. Hydrocodone bitartrate and acetaminophen 10mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.
Bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content could 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 overdose can potentially cause severe liver damage, at times resulting in liver transplant or death.
The affected lots, were distributed between Feb. 20, 2012 and Nov. 19, 2012 to wholesale distributors and retail pharmacies nationwide. The lot number can be found on the side of the manufacturers bottle. Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 16.51 mm in length, pink, capsule-shaped tablets, with 3600 debossed on one side of the tablet and V on the other.
It is very important that consumers do not exceed the maximum daily dose in the prescribing information for this product (no more than 6 tablets per day) and are fully aware of any other prescription or over-the-counter medications they may be taking that contain acetaminophen. If there is any doubt, a consumer should consult with their health care professional.
Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants.
No injuries have been reported to date.
Consumers who have the affected lots should contact Qualitest at 1-800-444-4011. Consumers who are unsure if they have the affected lot numbers or have any concerns about their product should consult their pharmacy or health care professional.
- Amatheon - Wholesale Veterinary Medicine - May 7th, 2011 [May 7th, 2011]
- Stronger Risk Management Program for Accutane (isotretinoin) - May 9th, 2011 [May 9th, 2011]
- Presentation of our company - May 13th, 2011 [May 13th, 2011]
- Value Drug Company - May 14th, 2011 [May 14th, 2011]
- erectile dysfunction videos - May 20th, 2011 [May 20th, 2011]
- Pet Pharmacy Vaccines- Buy Cheap Pet Supply Products Online - May 20th, 2011 [May 20th, 2011]
- Wholesale Supplements Sites (1) - May 22nd, 2011 [May 22nd, 2011]
- Reliance Wholesale - Who we are - May 22nd, 2011 [May 22nd, 2011]
- HCG Wholesale Source - May 31st, 2011 [May 31st, 2011]
- Vertical storage carousel, storage and retrieval for bin storage at Cecofar - May 31st, 2011 [May 31st, 2011]
- My Choice Meds - Online Medicinal Options - June 8th, 2011 [June 8th, 2011]
- Introducing GensourceRx - Authorized Pharmaceuticals Distributor - June 9th, 2011 [June 9th, 2011]
- AncientWay.com Chinese Herbal Pharmacy - June 12th, 2011 [June 12th, 2011]
- Generic Cialis - June 12th, 2011 [June 12th, 2011]
- H1N1 : Ukraine in panic. 8th November 2009 - June 18th, 2011 [June 18th, 2011]
- my pharmacy world drug mart - June 23rd, 2011 [June 23rd, 2011]
- Provigil Canada - June 26th, 2011 [June 26th, 2011]
- 1962 - I'm Not a Well Man - Barbra Streisand - I Can Get It For You Wholesale - June 29th, 2011 [June 29th, 2011]
- Retail struggles to find pharmacists -The Lempert Report - July 4th, 2011 [July 4th, 2011]
- Buy Kamagra - July 15th, 2011 [July 15th, 2011]
- Provigil drug - July 17th, 2011 [July 17th, 2011]
- Buy Dapoxetine - July 29th, 2011 [July 29th, 2011]
- Provigil vs Adderall - August 2nd, 2011 [August 2nd, 2011]
- Ajanta Kamagra - August 9th, 2011 [August 9th, 2011]
- Interview - Mark James, AAH - August 30th, 2011 [August 30th, 2011]
- Modafinil online pharmacy - September 4th, 2011 [September 4th, 2011]
- Marley Drug vs. WalMart - September 9th, 2011 [September 9th, 2011]
- What is Azithromycin - September 11th, 2011 [September 11th, 2011]
- California Board of Pharmacy Meeting September 7 2011 - September 16th, 2011 [September 16th, 2011]
- Vertical Carousel Pharmacy Automation Systems Sets the Stage For More Efficient Patient Care - September 20th, 2011 [September 20th, 2011]
- Track-and-trace Showcase, Toluca Mexico Feb 2011 (English) - September 25th, 2011 [September 25th, 2011]
- Vigora tablets - October 2nd, 2011 [October 2nd, 2011]
- Dydrogesterone uses - October 3rd, 2011 [October 3rd, 2011]
- Buy Zithromax - October 8th, 2011 [October 8th, 2011]
- Where to buy Diclofenac - October 8th, 2011 [October 8th, 2011]
- Dosage voltaren - October 9th, 2011 [October 9th, 2011]
- Nuvigil dosage - October 11th, 2011 [October 11th, 2011]
- Buy Alendronate - October 11th, 2011 [October 11th, 2011]
- Buy Zanaflex - Video - October 14th, 2011 [October 14th, 2011]
- Fosamax benefits - Video - October 15th, 2011 [October 15th, 2011]
- Ponstel side effects - Video - October 16th, 2011 [October 16th, 2011]
- Diflucan single dose - Video - October 17th, 2011 [October 17th, 2011]
- Buy Nolvadex UK - Video - October 17th, 2011 [October 17th, 2011]
- ACAI BERRY SELECT - Video - October 18th, 2011 [October 18th, 2011]
- Presentation of our company - Video - October 21st, 2011 [October 21st, 2011]
- Buy Viagra Generic and Save - Video - October 22nd, 2011 [October 22nd, 2011]
- Caverta tablet - Video - October 24th, 2011 [October 24th, 2011]
- Uses Herbolax - Video - October 27th, 2011 [October 27th, 2011]
- Where to buy Hoodia - Video - October 30th, 2011 [October 30th, 2011]
- Cheap Caverta - Video - November 4th, 2011 [November 4th, 2011]
- Where to buy Diclofenac - Video - November 5th, 2011 [November 5th, 2011]
- Generic Carbamazepine - Video - November 6th, 2011 [November 6th, 2011]
- Order Estradiol - Video - November 8th, 2011 [November 8th, 2011]
- Tablets Dostinex - Video - November 8th, 2011 [November 8th, 2011]
- Modalert review - Video - November 9th, 2011 [November 9th, 2011]
- Acomplia dosage - Video - November 10th, 2011 [November 10th, 2011]
- Dapoxetine India - Video - November 15th, 2011 [November 15th, 2011]
- Where to buy Voltaren - Video - November 17th, 2011 [November 17th, 2011]
- Acomplia buy UK - Video - November 18th, 2011 [November 18th, 2011]
- Price Voltaren - Video - November 21st, 2011 [November 21st, 2011]
- Purchase Voltaren - Video - November 27th, 2011 [November 27th, 2011]
- Drug store markups worth the cost? - Video - December 4th, 2011 [December 4th, 2011]
- Tablets Danazol - Video - December 6th, 2011 [December 6th, 2011]
- Priligy experience - Video - December 10th, 2011 [December 10th, 2011]
- Buy Acomplia cheap - Video - December 11th, 2011 [December 11th, 2011]
- Where to buy Bactrim - Video - December 13th, 2011 [December 13th, 2011]
- Dapoxetina Cloridrato - Video - December 14th, 2011 [December 14th, 2011]
- Dapoxetine sale - Video - December 15th, 2011 [December 15th, 2011]
- Acomplia diet drug - Video - December 17th, 2011 [December 17th, 2011]
- Cheap Acomplia online - Video - December 23rd, 2011 [December 23rd, 2011]
- Priligy pills - Video - December 25th, 2011 [December 25th, 2011]
- Cipralex Lexapro - Video - December 28th, 2011 [December 28th, 2011]
- Getting off Lexapro - Video - January 5th, 2012 [January 5th, 2012]
- Lexapro alternatives - Video - January 6th, 2012 [January 6th, 2012]
- Lexapro 20 mg - Video - January 6th, 2012 [January 6th, 2012]
- Modavigil - Video - January 10th, 2012 [January 10th, 2012]
- Modifilan side effects - Video - January 11th, 2012 [January 11th, 2012]
- Cipralex 10mg - Video - January 13th, 2012 [January 13th, 2012]
- Celexa Lexapro - Video - January 14th, 2012 [January 14th, 2012]
- Oral Jelly Kamagra - Video - January 14th, 2012 [January 14th, 2012]