8 Product Recalls Pharmacists Should Know


The FDA and pharmaceutical companies together initiated several noteworthy product recalls and market withdrawals in the last few months.

The FDA and pharmaceutical companies together initiated several noteworthy product recalls and market withdrawals in the last few months.

Pharmacists should review their stock to ensure that none of these products remain on their shelves:

1. All sterile compounded products from US Compounding, Inc.

Near the end of September, the FDA announced that US Compounding is voluntarily recalling all lots of its sterile products distributed nationwide to patients, providers, hospitals, or clinics between March 14, 2015, and September 9, 2015, due to concerns over a lack of sterility assurance.

This recall does not apply to the company’s non-sterile compounded medications.

2. Dietary supplements from One Minute Miracle

One Minute Miracle initiated a voluntary recall of all lots of its Miracle Diet 30 and Miracle Rock 48 dietary supplements due to the presence of undeclared products, making them unapproved drugs.

Miracle Diet 30 was found to contain undeclared phenolphthalein, an ingredient used in an OTC laxative that was removed from the market amid concerns of carcinogenicity, while Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of the FDA-approved male sexual enhancement drug sildenafil.

Because of this, the concomitant use of Miracle Rock 48 and nitrates could cause a sudden and significant drop in blood pressure, the FDA noted.

3. Sterile drug products from Medistat RX, LLC

At the beginning of September, the FDA announced that Medistat was voluntarily recalling all non-expired drug products produced for sterile use due to possible contamination.

Health care professionals are advised to check their medical supplies and quarantine any drugs marked as sterile from Medistat in order to avoid inadvertently administering them to patients.

The FDA has received reports of several cases of adverse effects that are potentially associated with Medistat’s products.

4. Herbal extracts from Iowa Select Herbs LLC

In August, a federal judge entered a consent decree of permanent injunction against Iowa Select Herbs LLC, a drug and dietary supplement manufacturer based in Iowa.

The manufacturer is prohibited from manufacturing and distributing unapproved drugs, misbranded drugs, adulterated dietary supplements, and misbranded dietary supplements, an FDA press release stated.

During an inspection in August 2014, the FDA discovered that Iowa Select Herbs was marketing its products as viable treatments for cancer, malaria, herpes, and heart disease, even though the FDA had not approved the company’s products for any use.

Before resuming operations, the company will be required to recall its products, hire labeling and current Good Manufacturing Practice experts, and receive permission from the FDA to manufacture and market its products.

The recalled products are herbal extracts marketed under the Iowa Select Herbs brand in either an alcohol or alcohol-free solution packaged in various sizes from 1 oz to 1 gallon.

5. 0.9% sodium chloride injections from Baxter

In early August, Baxter announced it was recalling a single lot of its 0.9% sodium chloride injection due to customer complaints of leaking containers, particulate matter, and missing port protectors, which could result in contamination.

Injecting a product containing particulate matter in the absence of in-line filtration may result in blockage of blood vessels, which can lead to stroke, heart attack, or damage to other organs. There is also potential for allergic reactions, local irritation, and inflammation in tissues and organs.

In a separate incident in July, Baxter recalled 2 lots of the injections due to the presence of insects.

6. Hydrochlorothiazide tablets from Unichem Pharmaceuticals

Pharmacists should be aware that a clopidogrel tablet found in a bottle of hydrochlorothiazide tablets prompted a product recall in early August.

Unichem Pharmaceuticals recalled 1 lot of hydrochlorothiazide tablets 25 mg packaged in 1000-count bottles.

The FDA warned that the risk associated with mistakenly taking a clopidogrel tablet instead of a hydrochlorothiazide tablet can increase the probability of experiencing clopidogrel's side effects, which include bleeding and/or bruising.

Additionally, missing a dose of hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid, as the drug is indicated to treat high blood pressure and edema.

7. Calcium chloride intravenous infusion 10% prefilled syringe from Mylan

Mylan initiated a voluntary market withdrawal of 14 lots of its calcium chloride intravenous infusion prefilled syringes in April, but the FDA learned over the summer that some recalled units were still on the market.

The company initiated the market withdrawal after receiving complaints from customers that the syringe was not compatible with certain needleless adaptors. This is especially precarious because the solution is used in lifesaving resuscitation procedures after cardiac arrest.

The affected lots were distributed in the United States between March 19, 2014, and February 24, 2015, and packaged with an Agila and Amneal label.

8. Compounded human and veterinary drugs from Moses Lake Professional Pharmacy

Moses Lake Professional Pharmacy in Washington compounded now-recalled human and veterinary drugs between July 21, 2014, and July 21, 2015. The products were then dispensed to patients or distributed to physicians to administer to patients in Arizona, Idaho, Florida, Oregon, Texas, and Washington.

The compounder issued the recall after an inspection identified an issue with sterility assurance. All recalled products have a label that includes the pharmacy name and the name of the compounded drug product.

The recall does not affect any non-sterile compounded medications it prepared, or any sterile products the pharmacy compounded after July 21, 2015.

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