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Drugs recalls

Finished prescription and over-the-counter drugs that patients can identify from packaging or pharmacy records.

Limited official informationDrugs

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

AffectedAmlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Labo...
RiskFailed Dissolution Specifications; Olmesartan Medoxomil content below specifications
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Ka...

Presence of Particulate Matter: Hair was found in product

AffectedGlycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose...
RiskPresence of Particulate Matter: Hair was found in product
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes,...

Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.

AffectedGlycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-...
RiskDue to an out-of-specification result for an unidentified impurity detected during routine stability testing.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharm...

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

AffectedLidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed...
RiskLabeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only,...

Presence of Particulate Matter: Hair was found in products

AffectedNaropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-D...
RiskPresence of Particulate Matter: Hair was found in products
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Br...

Presence of Precipitate: medication was crystallizing and particles floating in the bottle

AffectedRising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Hol...
RiskPresence of Precipitate: medication was crystallizing and particles floating in the bottle
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL)...

Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

AffectedBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/cart...
RiskLack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the appli...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-05...

Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

AffectedNystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham,...
RiskSubpotent Drug: Low out of specification assay results performed during long-term stability testing.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15)

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

AffectedQC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bot...
RiskSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 8009...

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

AffectedMedline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive,...
RiskFailed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL ap...

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

AffectedBD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as...
RiskLack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and st...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

AffectedCinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, Ind...
RiskcGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsu...

Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

AffectedDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Ex...
RiskLabeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THY...

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

AffectedGemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only,...
RiskTemperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigera...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufa...

CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

AffectedGlucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syri...
RiskCGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability test...
ActionNot available

Missing from associated official evidence: action.