Recalls That Should Be on Your Radar—Week of April 12, 2020

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Avet Pharmaceuticals Issues Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications

Avet Pharmaceuticals Inc. of New Jersey is initiating a voluntary recall of lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level due to dissolution problems.

Low dissolution leads to less tetracycline available in the patient’s body to fight infection. This can lead to treatment failure. For patients who are immunocompromised and older, who may be taking tetracycline to treat a serious infection such as pneumonia, there is a reasonable chance that if there is not enough tetracycline in the body to fight the infection, this could result in rapid progression of the infection and death. To date, Avet has not received adverse event reports or complaints related to this event.

Tetracycline HCl Capsules USP, 250 mg and 500 mg are indicated in the treatment of infections caused by susceptible strains of the designated organisms, including upper and lower respiratory infections, skin and soft tissues infections, infections caused by Rickettsiae, as adjunctive therapy in severe acne.

Read the recall statement.

Auromedics Pharma LLC Issues Recall of Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in Vial

AuroMedics Pharma LLC of New Jersau has issued a voluntarily recall of lot AF0117001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The affected product has been found to contain glass particles.

Glass particulate may result in local irritation or swelling in response to the foreign material when administered intravenously.

More serious outcomes include blockage and clotting in blood vessels.

AuroMedics Pharma LLC has not received reports of adverse events or identifiable safety concerns attributed to the product.

Ampicillin and Sulbactam for Injection is used for treatment of infections due to susceptible strains in skin and skin structure infections, intra- abdominal infections and gynecological infections in adults as well as for treatment of skin and skin structure infection in pediatric patients one year and older.

Read the recall statement.

Evershing International Trading Company Issues Recall of Frozen Shredded Coconut Because of Possible Salmonella Contamination

Evershing International Trading Company has issued a recall of Coconut Tree Brand Frozen Shredded Coconut, 16 oz., because some products may be contaminated with Salmonella.

The issue was discovered during testing performed by the State of Massachusetts.

Salmonella can cause serious infections in young children, older adults, and those with immunocompromising conditions. Healthy individuals may experience nausea, vomiting and abdominal pain, among other symptoms.

Read the recall statement.

International Laboratories, LLC Issues Recall of 1 Lot of Clopidogrel Tablets USP, 75 mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A

International Laboratories, LLC has issued a voluntarily recall of Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling.

Improper doses of Clopidogrel increases the risk of heart attack and stroke which can be fatal.

Read the recall statement.

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of N-nitrosodimethylamine (NDMA) Impurity Amounts Above the Levels Established by FDA.

NDMA is a probable human carcinogen. No reports of adverse events have been reported to date.

Nizatidine is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers, esophagitis, and associated heartburn due to gastroesophageal reflux disease.

Read the recall statement.

PharMEDium Services, LLC Issues Recall of Specific Lots of Compounded Sterile Products Due to Lack of Sterility Assurance

PharMEDium Services is issuing a voluntary recalling the below lots of drug products to the hospital/user level due to a lack of certainty about the sterility of some products.

Administration of a drug product intended to be sterile that is not sterile could result in serious infections. PharMEDium has not received any reports of complaints related to the products but is issuing the recall out of caution following a recent inspection of the company’s facility.

Read the recall statement.

AuroMedics Pharma LLC Issues Recall of Levofloxacin in 5% Dextrose 250mg/50mL Due to Presence of Visible Particulate Matter Which May Be Mold

AuroMedics Pharma is issuing a recall for one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL, Lot CLF160003, Expiry date May 2018, to the hospital level.

The product has been found to contain visible particulate matter believed to be a mold. The problem was brought to light over a product complaint in which the contents of one flexible bag was found to contain white particulate matter.

Use of a non-sterile product could result in fatal infections in a broad array of patients. AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns related to the product being recalled.

Read the recall statement.

Pharmedium Services Issues Expansion of Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance

PharMEDium Services, LLC has expanded a recall issued on December 27, 2017 to include further lots of sterile drug products to the hospital/user level due to a lack of assurance of sterility.

Administration of a drug product intended to be sterile that is not could result in serious infections. To date, PharMEDium has not received any reports of adverse events related to the products but is issuing a recall out of an abundance of caution.

Read the recall statement.