Content about Product Recall

February 18, 2014

The one-time $100 million asthma-relief brand Primatene may make a comeback to the marketplace after a more than two-year hiatus.

The one-time $100 million asthma-relief brand Primatene may make a comeback to the marketplace after a more than two-year hiatus. Primatene Mist had been withdrawn from the market in December 2011 when the agency removed all inhalers containing chlorofluorocarbons from the market.

February 13, 2014

After meeting for two days earlier this week, the Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-9 against changing the label of naproxen to highlight a lower cardiovascular risk profile as compared to other NSAIDs, according to published reports.

SILVER SPRING, Md. — After meeting for two days earlier this week, the Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-9 against changing the label of naproxen to highlight a lower cardiovascular risk profile as compared to other NSAIDs, according to published reports. 

Those advisory panels who voted against the change felt the data were insufficient to say naproxen was safer than other NSAIDs.

November 20, 2013

Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday.

SILVER SPRING, Md. — Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday. 

November 11, 2013

The Food and Drug Administration on Sunday announced that USPlabs of Dallas is recalling certain OxyElite Pro dietary supplement products that the company markets.

SILVER SPRING, Md. — The Food and Drug Administration on Sunday announced that USPlabs of Dallas is recalling certain OxyElite Pro dietary supplement products that the company markets. 

The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses, and that there is a reasonable probability that the products are adulterated.  

November 4, 2013

Perrigo on Friday initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid.

ALLEGAN, Mich. —  Perrigo on Friday initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings. 

May 13, 2013

A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

SILVER SPRING, Md. — A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

March 25, 2013

LifeScan initiated a voluntary recall and replacement for all of its OneTouch VerioIQ blood-glucose meters in the United States, effective immediately.

MILPITAS, Calif. — LifeScan on Monday initiated a voluntary recall and replacement for all of its OneTouch VerioIQ blood-glucose meters in the United States, effective immediately.

December 21, 2012

A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.

CHADDS FORD, Pa. — A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.

The U.S. District Court for the District of Columbia dismissed a case filed by Endo subsidiary Endo Pharmaceuticals against the Food and Drug Administration, in which the company had argued that the FDA failed meet a legal obligation to determine whether the original formulation of Opana ER (oxymorphone) extended-release tablets was withdrawn from the market for safety reasons.

October 19, 2012

Smokers who have been unsuccessful to date in trying to kick the nicotine habit may be able to stop smoking by combining two smoking cessation approaches, according to a report published in the Oct. 17 issue of JAMA.

BOSTON — Smokers who have been unsuccessful to date in trying to kick the nicotine habit may be able to stop smoking by combining two smoking cessation approaches, according to a report published in the Oct. 17 issue of JAMA.  

September 25, 2012

Generic drug maker Watson Labs recalled two lots of a prescription painkiller due to the potential for oversized and overly potent tablets, the company said.

PARSIPPANY, N.J. — Generic drug maker Watson Labs recalled two lots of a prescription painkiller due to the potential for oversized and overly potent tablets, the company said.

The drug maker announced the recall of hydrocodone bitartrate and acetaminophen tablets in the 10 mg/500 mg strengths based on a customer complaint of tablets that were thicker and darker-colored than the others.

July 20, 2012

Albertsons Market is implementing the Recall InfoLink product recall management platform into its pharmacy operation to help it streamline the process of managing recalls, the grocer confirmed on Friday.

BOISE, Idaho — Albertsons Market is implementing the Recall InfoLink product recall management platform into its pharmacy operation to help it streamline the process of managing recalls, the grocer confirmed on Friday.

Recall InfoLink is a patented, Web-based product recall management system designed to improve recall efficiency by providing standardized messages, automated communications, inventory tracking and reports for compliance efforts.

Albertsons Market operates more than 200 stores in Arizona, Arkansas, Colorado, Florida, Louisiana, New Mexico and Texas.

May 18, 2012

McNeil Consumer Healthcare on Thursday informed its wholesale customers that it is voluntarily recalling one lot of Imodium multi-symptom relief 18 caplets due to a packaging issue that may have impacted a limited number of blister units in this lot.

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Thursday informed its wholesale customers that it is voluntarily recalling one lot of Imodium multi-symptom relief 18 caplets due to a packaging issue that may have impacted a limited number of blister units in this lot.

The product is being recalled at the wholesale level only, and not from consumers or from store shelves, as there are no safety concerns or adverse events related to the reason for the recall. The lot number (CMF023) for the recalled product can be found on the side of the product box.

February 28, 2012

The U.S. unit of Indian generic drug maker Glenmark is recalling a generic contraceptive drug, the company said.

NEW YORK — The U.S. unit of Indian generic drug maker Glenmark is recalling a generic contraceptive drug, the company said.

Glenmark Generics USA announced the recall of seven lots, imported from India, of norgestimate and ethinyl estradiol tablets in the 0.18-mg/0.035-mg, 0.215-mg/0.035-mg and 0.25-mg/0.035-mg strengths. The company said a packaging error resulted in blister packs being rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiration date visible only on the outer pouch.

February 1, 2012

A possible pill mix-up has prompted Pfizer to recall more than two dozen lots of a prescription contraceptive drug, the drug maker said.

NEW YORK — A possible pill mix-up has prompted Pfizer to recall more than two dozen lots of a prescription contraceptive drug, the drug maker said.

Pfizer announced the voluntary nationwide recall of 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 additional lots of the drug's generic version. Pfizer manufactured and packaged the drugs, while Akrimax Pharmaceuticals commercialized them, and they were sold under the Akrimax brand.

December 22, 2011

McNeil Consumer Healthcare on Wednesday issued a voluntarily recall of certain lots of Motrin IB coated tablets from retailers.

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Wednesday issued a voluntarily recall of certain lots of Motrin IB coated tablets from retailers. "This is not a consumer-level recall, which means that consumers do not need to dispose of or return the product," McNeil stated. 

McNeil is recalling these products because testing of product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date.

November 21, 2011

Factor Nutrition Labs on Monday presented a study supporting supplementation with its FocusFactor product to improve brain function before the Gerontological Society of America.

BOSTON — Factor Nutrition Labs on Monday presented a study supporting supplementation with its FocusFactor product to improve brain function before the Gerontological Society of America.

November 1, 2011

Drug maker Impax Labs reported sales of $119.8 million and profits of $20 million in third quarter 2011, according to an earnings report released Tuesday.

HAYWARD, Calif. — Drug maker Impax Labs reported sales of $119.8 million and profits of $20 million in third quarter 2011, according to an earnings report released Tuesday.

The latest sales figures represented a $12.2 million increase over third quarter 2010, while profits were $4.2 million higher.

October 25, 2011

Eli Lilly is withdrawing one of its drugs from the market after clinical trials showed it to be ineffective.

INDIANAPOLIS — Eli Lilly is withdrawing one of its drugs from the market after clinical trials showed it to be ineffective.

The drug maker announced Tuesday the withdrawal of Xigris (drotrecogin alfa [activated]) from all markets following results of the "PROWESS-SHOCK" study, which found that it did not produce a statistically significant reduction in 28-day, all-cause death in patients with septic shock. The company said there were no new findings regarding the drug's safety profile.

October 11, 2011

Sales of antacid tablets are up almost 3%. And while nobody is suggesting that upward trajectory is going to change anytime soon, there will be a decent amount of volatility in the coming year.


Sales of antacid tablets are up almost 3%. And while nobody is suggesting that upward trajectory is going to change anytime soon, there will be a decent amount of volatility in the coming year.


September 22, 2011

It seems that Tylenol Cold & Flu Severe caplets are making their way back to store shelves, according to published reports.

NEW YORK — It seems that Tylenol Cold & Flu Severe caplets are making their way back to store shelves, according to published reports.

According to several reports, McNeil Consumer Healthcare spokeswoman Bonnie Jacobs confirmed that the product, which is designated for adult use, will begin shipping this week.

McNeil Consumer Healthcare, a Johnson & Johnson subsidiary, recalled several lots of Tylenol products due to reports of uncharacteristic odor, which was linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).

July 13, 2011

Product recalls over the past two years have eroded consumer trust in over-the-counter drugs; however, those same recalls represent opportunity for smaller market players to gain exposure and build brand awareness, wrote Laura Mahecha, industry manager for health care at research firm Kline, in an online report issued Wednesday.

PARSIPPANY, N.J. — Product recalls over the past two years have eroded consumer trust in over-the-counter drugs; however, those same recalls represent opportunity for smaller market players to gain exposure and build brand awareness, wrote Laura Mahecha, industry manager for health care at research firm Kline, in an online report issued Wednesday. In addition, private-label brands and “natural OTCs” are enjoying strong growth. 

June 29, 2011

McNeil Consumer Healthcare on Tuesday initiated another recall at the retail level of one product lot (60,912 bottles) of Tylenol extra strength caplets in 225-count bottles because of a small number of odor reports, including a musty, moldy odor.

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Tuesday initiated another recall at the retail level of one product lot (60,912 bottles) of Tylenol extra strength caplets in 225-count bottles because of a small number of odor reports, including a 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).

The product lot number (ABA619) for the recalled product can be found on the side of the bottle label. The recalled product was manufactured in February 2009.

June 20, 2011

Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.

TITUSVILLE, N.J. — Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.

J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals announced the voluntary recall of one lot of Risperdal (risperidone) tablets in the 3-mg strength and a lot of authorized generic risperidone tablets in the 2-mg strength made by Patriot Pharmaceuticals, also a J&J subsidiary.

June 6, 2011

The Food and Drug Administration has found manufacturing issues at a plant owned by generic drug maker Impax Labs, the drug maker said Monday.

HAYWARD, Calif. — The Food and Drug Administration has found manufacturing issues at a plant owned by generic drug maker Impax Labs, the drug maker said Monday.

May 12, 2011

A subsidiary of Johnson & Johnson is recalling several batches of an HIV drug after reports of a strange odor that may have come from the shipping pallets.

HIGH WYCOMBE, United Kingdom — A subsidiary of Johnson & Johnson is recalling several batches of an HIV drug after reports of a strange odor that may have come from the shipping pallets.

Janssen-Cilag International said it would recall five lots of Prezista (darunavir) due to consumer reports of a musty or moldy smell coming from them. The odor is believed to result from traces of the chemical TBA, which is used in the construction of the pallets. The recalled lots were found in Canada, the United Kingdom, Ireland, Germany and Austria.