FDA Recalls You Should Know About—Week of July 1, 2018

Blissful Remedies Issues Recall of Certain Kratom Powder Capsules Linked to Salmonella

Blissful Remedies., is voluntarily recalling kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have Salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines.

For more information on the recall, check out the official news release.

Fagron Sterile Services Issues Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services is voluntarily recalling 2 lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labeled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labeled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL.

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Risk Statement: In the event that 5mL rather than the intended 3mL is administered to a patient, adverse events from Neostigmine Methylsulfate overdosage can range from nausea, vomiting, diarrhea, excessive salivation and sweating, increased bronchial secretions, miosis, bradycardia or tachycardia, cardiospasm, bronchospasm, incoordination, muscle cramps, fasciculation, paralysis, to Cholinergic Crisis resulting in death. To date, Fagron has not received any reports of adverse events or injuries related to this recall.

For additional details, read the official statement.

FDA Issues Warning About MedGyn Product’s Monsel’s Solution

The FDA advises health care professionals not to use any Monsel’s Solution (ferric subsulfate 20%) because the drug product was made under poor conditions. The solution is manufactured by BioDiagnostics International, Brea, California, and distributed by MedGyn Products, Inc., Addison, Illinois.

BioDiagnostics notified MedGyn of the recall of all lots of Monsel’s Solution on June 11, 2018. However, MedGyn has not yet notified its customers to remove any distributed drug product from the market.

Monsel’s Solution is used to stop bleeding after medical procedures, such as a colposcopy and a biopsy. The solution is sold in a carton containing 12 single application vials and 12 applicators, 8 mL each, NDC 42721-112-08. Health care professionals should immediately check their medical supplies, quarantine any of MedGyn’s Monsel’s Solution, and not administer it to patients.

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