Norethindrone/Ethinyl Estradiol (ORTHO-NOVUM) Recalled Due to Incorrect Instructions

November 10, 2018
Krista Rossi

Not sure what’s been recalled, withdrawn from the market, or had safety updates? Catch up on the US Food and Drug Administration’s (FDA's) recalls and safety news from this past week.

Norethindrone/Ethinyl Estradiol (ORTHO-NOVUM) Recalled Due to Incorrect Veridate Dispenser Instructions

Due to a lack of the appropriate instructions for the Veridate dispenser, Janssen Pharmaceuticals is voluntarily recalling 1 lot of ORTHO-NOVUM 1/35 (norethindrone/ethinyl estradiol) Tablets and 2 lots of ORTHO-NOVUM7/7/7 (norethindrone/ethinyl estradiol) Tablets.

Since the recalled products are intended for contraceptive uses, a lack of appropriate instructions for correct use could pose a potential risk to patients as they could take the pills in the incorrect order. Although patients could still receive an effective dose, they could also take an inactive "reminder" pill instead of an "active" pill, which could result in breakthrough bleeding or an unintended pregnancy.

However, with the appropriate dispenser instructions, the products are safe and effective for use. “Women should continue to take the 21 "active" pills (with hormones) (peach for norethindrone/ethinyl estradiol 1/35; white, light-peach and peach for norethindrone/ethinyl estradiol 7/7/7) for 3 weeks, followed by the 1 week of green "reminder" pills (without hormones).”

For more information on this recall, read the FDA’s statement.

Puriton Eye Relief Drops Recalled Due to Non-Sterile Production Conditions

Due to non-sterile production conditions, Kadesh, Inc. is voluntarily recalling all lots of Puriton Eye Relief Drops, .5 oz. (15ml) bottle, UPC 7 36972 1679 0.

Intended for temporary eye relief pertaining to burning and irritation, Puriton Eye Relief Drops are over-the-counter homeopathic eye drops used to treat burning and irritation that may result from dryness of the eye and discomfort caused by minor irritations of the eye or to exposure to wind or sun.

Potentially vision-threatening due to the risk of an eye infection, non-sterile eye drops can destroy tissues in the cornea, anterior chamber, and deeper structures of the eye. These potential risks can occur since the pH of the product is relatively high, and they can lead to scarring, glaucoma, or vision loss.

Currently, no occurrences of adverse events have been reported for this recall.

For more information on this recall, read the FDA’s statement.

Losartan Potassium & Hydrochlorothiazide Recalled Due Trace Amounts of N-Nitrosodiethylamine (NDEA)

Due to the trace amount of N-nitrosodiethylamine (NDEA) impurity found in the active pharmaceutical ingredient (API) Losartan, Sandoz Inc. is voluntarily recalling 1 lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg. Losartan is indicated for the treatment of hypertension.

Classified as a probable human carcinogen, according to International Agency for Research on Cancer (IARC), the impurity is a substance that occurs naturally in certain foods, air pollution, drinking water, and industrial processes.

Currently, no occurrences of adverse events have been reported for this recalled lot.

For more information on this recall, read the FDA’s statement.

Inaccurate Magnetic Resonance Thermometry Risks Tissue Overheating

The FDA has provided an update regarding the potential risks of tissue overheating due to potentially inaccurate magnetic resonance (MR) thermometry readings in the use of magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) devices.

The additional recommendations aim at helping protect patient safety; a series of initial advisory letters precede the update.

Presently, 2 manufactures that market MRgLITT devices are involved—Medtronic with its Visualase Thermal Therapy System, and Monteris Medical with its NeuroBlate System. The updates include detailed guidelines for temperature control and setting.

For more information on this update, read the FDA’s statement.

For FDA recalls and safety updates regarding food products, visit Contagion®’s recall list.


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