Antibiotic Medicine Recalled After Product Incorrectly Packaged: FDA

Consuming the wrong type of antibiotic could result in potentially fatal consequences.

An image of the recalled Cefazolin medicine label. Courtesy of the FDA

Sandoz is voluntarily recalling one lot of Cefazolin for incorrectly including a different antibiotic in its packaging, according to a June 27 Food and Drug Administration (FDA) announcement.

The lot is being recalled following a customer complaint indicating that four Penicillin G Potassium were incorrectly included in a carton of Cefazolin.

“There is a reasonable probability that the inadvertent administration of penicillin G potassium injection, instead of intended cefazolin injection, may pose serious and potentially life-threatening adverse health consequences, including lack of efficacy leading to less than optimal treatment of severe infections, antibiotic resistance, adverse reactions, severe allergic reactions (e.g., anaphylaxis), drug interactions, cardiac arrhythmias resulting from high potassium especially in patients with kidney impairment, and delayed recovery,” the recall notice reads.

Sandoz is based in Switzerland and its U.S. branch office is in New Jersey.

The company has not received any reports of adverse events or injuries related to the recall. However, Sandoz received a complaint of “inadvertent administration of the incorrect product to a patient.”

Cefazolin is used for the treatment of pneumonia and to prevent bacterial infections during surgery, while Penicillin G Potassium is used for the treatment of certain serious infections including septicemia, skin, wound infections, and a host of other diseases including peritonitis, meningitis/brain abscesses, rat bite fever, anthrax, tetanus, complications in gonorrhea and syphilis and Lyme.

Both antibiotics belong to the beta-lactam group of antibiotics and are indicated for adults, the elderly, and pediatric patients, including newborns.

However, they are prescribed for different types of infections, and each “medicine has specific on-label distinct groups, and the dosing regimens may differ,” according to the notice.

Sandoz is arranging for its return after the product was shipped for nationwide distribution. Physicians and patients with the product are warned not to use it and to contact Sedgwick, the Sandoz Reverse Distributor, directly by phone or email to arrange the return. The FDA has published the distributor’s contact information.

Adverse reactions may be reported to Sandoz or the FDA’s MedWatch Adverse Event Reporting program.

The Epoch Times reached out to Sandoz for comment but did not receive a response by publication time.

Microbial Contamination

Earlier this month, the FDA issued recall notices for other medical products such as Sulfamethoxazole tablets and nasal and baby teething swab products.

On June 4, the FDA announced the recall of three lots of Sulfamethoxazole/Trimethoprim tablets because of microbial contamination by Amneal Pharma.

In a June 6 FDA announcement, New Jersey-based Church & Dwight Co. recalled three nasal and baby teething swab products because of potential fungal contamination in the cotton swab components.

The recall was applicable to three products: Zicam Cold Remedy Nasal Swabs designed to tackle the common cold, Zicam Nasal AllClear Swabs used for cleansing, and Orajel Baby Teething Swabs aimed at soothing teething discomfort among toddlers and infants.

Individuals with chronic lung disease, HIV, and cancer face a higher risk of fungal diseases, the Centers for Disease Control and Prevention said in a May 8 statement. This is also true for people undergoing treatments such as organ transplants, stem cell transplants, and taking medications like high doses of antibiotics.

If a person ingests a wrong medicine, they are advised to immediately call Poison Help at 1-800-222-1222, which connects to a local poison center.

Every poisoning is different, and the treatment depends on the type and amount of poison involved, along with the individual’s age and medical history.