Drug and pharmaceutical recalls

PReye LLC is recalling all lots of PReye Vitamin See Antioxidant Preservative Free Eye Drops due to lack of assurance of sterility. The recall affects approximately 50 to 60 bottles distributed in Colorado. No injuries have been reported.

ANI Pharmaceuticals is recalling hydroxyzine hydrochloride oral solution (10 mg/5 mL, 473 mL bottles) due to the presence of a foreign substance in one lot. The affected product was distributed nationwide. No injuries have been reported.

Central Admixture Pharmacy Services issued a recall for one patient-specific Total Parenteral Nutrition (TPN) bag that did not contain copper and famotidine as listed on the label. The bag was prepared for a pediatric patient in Massachusetts. No injuries have been reported.

Direct Rx's packaged Duloxetine D/R 30 mg capsules contain levels of N-nitroso-duloxetine, a potentially harmful impurity, above FDA's recommended limit. This is a manufacturing quality issue affecting specific lots distributed nationwide.

Amgen is recalling Sensipar (cinacalcet) 90mg tablets due to deviations from current good manufacturing practice (CGMP) standards. This affects one lot distributed nationwide. No injuries have been reported.

Amgen is recalling specific lots of Corlanor (ivabradine) 7.5mg tablets due to the presence of a foreign substance in some bottles. The affected lots were distributed nationwide. No injuries have been reported.

Amgen is recalling Sensipar (cinacalcet) 60mg tablets due to deviations from manufacturing standards. The recall affects one lot (1157055) with an expiration date of January 31, 2028, distributed nationwide.

Amgen is recalling Sensipar (cinacalcet) 30mg tablets due to deviations from manufacturing quality standards (CGMP). The recall affects one specific lot distributed nationwide. No injuries have been reported.

Amgen has recalled multiple lots of Corlanor (ivabradine) 5 mg tablets due to the presence of a foreign substance in some bottles. The affected tablets are packaged in 14-tablet and 60-tablet bottles distributed nationwide. No injuries have been reported.

Ajanta Pharma USA Inc. is recalling one lot of fenofibrate 200 mg capsules due to manufacturing quality deviations discovered during inspection. The affected lot (PA02216, expiring 12/2029) was distributed nationwide.

MAJOR Pharmaceuticals is recalling Methylergonovine Maleate Tablets, USP, 0.2 mg due to subpotency — meaning the tablets contain less active ingredient than labeled. The affected lots were distributed nationwide. This is a prescription medication used to control bleeding after childbirth.

The FDA identified manufacturing deficiencies during inspection of Med Pride Triple Antibiotic Ointment (1oz tubes). Multiple lots do not meet required manufacturing standards. No injuries have been reported.

Med Pride Triple Antibiotic Ointment packets were found to have manufacturing quality deficiencies during an FDA inspection. The affected lots do not meet federal quality standards, though no injuries have been reported.

The FDA found manufacturing deficiencies during an inspection of the facility that produces Med Pride Hydrocortisone Cream 1%. These deviations from proper manufacturing standards affected multiple lots of the product currently still within their expiration dates.

The FDA found manufacturing quality control problems (CGMP deviations) during an inspection of the facility that makes Med Pride Hydrocortisone Cream 1%. Multiple lots of the product are affected. No injuries have been reported.

The FDA found manufacturing deficiencies during an inspection of Med Pride 1% Clotrimazole Antifungal Cream. These deficiencies do not meet federal good manufacturing practice standards. About 5,755 tubes across multiple lots are affected.

The FDA found manufacturing deficiencies during an inspection of the facility that made Med Pride Bacitracin Zinc Ointment. This affects specific batches (Lot #022, 023, and 024) distributed nationwide.

The FDA found manufacturing quality control problems during an inspection of the facility that produced Med Pride Bacitracin Zinc Ointment. This ointment is used to help prevent infection in minor cuts and scrapes. The affected batches were distributed nationwide.

The FDA identified manufacturing quality control problems during an inspection of the facility that produces Med Pride Bacitracin Zinc Ointment. Certain lot numbers do not meet federal manufacturing standards for sterile wound-care products.

Dabur India Limited's Cura Hongos antifungal cream (clotrimazole 1%, 2oz tubes) was found to have manufacturing deficiencies during an FDA inspection. The affected product (Lot #0003) does not meet U.S. manufacturing standards. No injuries have been reported.

The FDA found manufacturing deficiencies during an inspection of the facility that made Rapidol Triple Antibiotic First Aid Ointment. The product does not meet federal manufacturing standards. About 84 tubes (Lot 0004) were distributed nationwide.

The FDA identified manufacturing deficiencies during an inspection of this triple antibiotic ointment product. The affected lot (0005) is still within its expiration date. No injuries have been reported.

Circle K triple antibiotic ointment tubes manufactured by Dabur India Limited have been recalled due to deficiencies found during an FDA inspection. The affected lots (0001 and 0005) do not meet current manufacturing standards for sterile products.

The FDA inspected the manufacturer of Lucky Super Soft First Aid Triple Antibiotic Ointment and found deficiencies in how the product was made and quality-controlled. The affected tubes are lot numbers 0002 and 0003, which are still within their expiration dates.

Dabur India Limited's Lucky Super Soft Antifungal Athlete's Foot Cream (Clotrimazole 1%, 1.5 oz tubes) is being recalled due to manufacturing deficiencies found during an FDA inspection. The affected lots (0001 and 0002) were distributed nationwide.

Inventia Healthcare Limited's chlorthalidone 25 mg tablets failed to meet dissolution specifications, meaning the tablets may not break down properly in the body and deliver the full dose. This affects 100-tablet and 1000-tablet bottles distributed nationwide. No injuries have been reported.

Sandoz is recalling one lot of Focalin XR (dexmethylphenidate HCl) 5 mg extended-release capsules because some bottles have incorrect or missing lot numbers and expiration dates on the label. The affected lot (VA0099422) was distributed nationwide. This is a labeling issue only; the medication itself has not been found to be unsafe.

Safco SensiCaine-Ultra topical anesthetic gel bottles may have incomplete seals, which could allow the product to leak or become contaminated. This affects 150 units distributed nationwide. No injuries have been reported.

PureLife topical anesthetic gel (benzocaine 20%, 1 oz) may contain bottles with incomplete seals. This could allow the product to leak or become contaminated. About 450 units were distributed nationwide.

Dental City topical anesthetic gel (benzocaine 20%, strawberry flavor) may contain bottles with incomplete seals. This defect could allow the product to leak or become contaminated. The recall affects 450 units distributed nationwide.