Recalls

Birth-control Pill Mishap Leads to Lawsuits, Baby Boom

In the aftermath of a pharmaceutical packaging error, patients are giving birth to surprise babies, and some are litigating.

Shanta Russell had been taking her birth-control pills faithfully for more than a dozen years without a hitch. So when pregnancy tests kept turning up positive in June 2011, she was stunned.

Shock turned to anger three months later when the single Kansas City woman received a recall notice in the mail warning that the pills she had taken may have been placed in the wrong order in their blister packs. The mistake could render the pills ineffective.

Novartis Consumer Health Recalls Certain Lots of Triaminic and Theraflu, Concerned about Child Resistance

Novartis Consumer Health Inc. is reporting on its Web site that it is "voluntarily recalling certain lots of Triaminic Syrups and Theraflu Warming Relief Syrups that were manufactured in the United States before December 31, 2011." The company reports that it is recalling the lots "because the child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place," it states on its Web site.

Matrixx Initiatives Recalls Zicam Due to Bacterial Contamination

The makers of the liquid nasal gel, used as a decongestant, are recalling one lot of the 0.5-oz spray bottles.

Matrixx Initiatives is voluntarily recalling 1 lot of Zicam® Extreme Congestion Relief nasal gel. The company is taking this step after finding a small amount of Burkholderia cepacia in a single sample of the product taken from the affected lot. The problem was detected during a routine review at the manufacturing facility. Tests on additional samples from the same lot have shown no evidence of the organism.

Resource Maintenance Software to Aid Manufacturers in Preventing Recalls

Valdata has launched a campaign to help manufacturers and pharmaceutical packaging partners to manage maintenance and avoid recalls.

In light of the increasing number of manufacturer recalls, Valdata Systems has launched a campaign focusing on educating manufacturers on ways to ensure proper maintenance of equipment and prevent future recalls.

Valdata has developed an integrated set of modules within its Chemical Management System (“CMS”) which enforcesresource maintenance rules. The result is a higher level of protection from quality issues resulting in product recalls.

Boehringer Ingelheim Pharmaceuticals Recalls Pradaxa Capsules in U.S., Puerto Rico

The firm is recalling one lot of the drug, indicated to reduce the risk of stroke and systemic embolism in patients with NVAF.

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that it is conducting a nationwide voluntary recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate), 75mg 60 US, NDC 0597- 0149-54, lot 201900, Exp January 2015. PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). The recall is limited to this one lot number.

Sun Pharmaceutical Recalls Nimodipine Capsules

Sun Pharmaceutical Industries, Inc. (Sun Inc) announced today that it is voluntarily recalling from users one lot of Nimodipine Capsules, 30 mg, marketed by Caraco Pharmaceutical Laboratories, Ltd. Sun Inc. commenced the recall as a precautionary measure due to the presence of crystals of nimodipine within the capsule solution of this lot as identified by a customer complaint. No adverse events have been reported at this time.

Westone Labs Recalls Ear Lubricant Citing Possible Microbe Contamination.

Westone Laboratories, Inc. is initiating a voluntary nationwide recall of all sizes and packaging configurations of Oto-Ease ear lubricant. The products have been found through a consumer complaint and the U.S.

Nidek Medical Products Recalls Oxygen Concentrators

The devices reportedly contain a capacitor susceptible to failure and possible fire.

Nidek Medical Products, Inc., today announced that the U.S. Food and Drug Administration (FDA) has classified Nidek’s voluntary recall action regarding capacitor-related fires in Medical Mark5 Nuvo Lite Oxygen concentrators as a Class I recall.

Moog Medical Devices Group Recalls Curlin Administration Sets

Use of the affected sets could cause desanguination, under-delivery of prescribed medication or therapy delay.

Moog Medical Devices Group (MMDG) is issuing a voluntary recall for certain lots of Curlin Intravenous Administration Sets. Use of the affected sets may cause desanguination (blood loss), an under-delivery of prescribed medication/fluid, or a potential delay in therapy. Continued use of the affected administration sets may cause a potential risk of serious injury or death.

The following REF (catalog) and lot numbers, which were sold and distributed in the U.S. between December 2011 and May 2012, are included in the recall:

Hospira Recalls Morphine Sulfate Injection Syringes

The company issued the recall after customers reported detecting syringes containing more than the labeled fill volume.

Hospira Inc. is initiating a voluntary user level recall of one lot of Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1258-30, due to a customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume.

Opioid pain medications such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

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