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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

Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick,...

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

AffectedXyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories...
RiskLabeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majo...

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

AffectedNicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis...
RiskFailed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life s...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus...

Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

AffectedAtomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg b...
RiskLabeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distribute...

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

AffectedErythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedaba...
RiskCGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN...

Defective Container; packets were found to be either empty or partially full.

AffectedEstradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals,...
RiskDefective Container; packets were found to be either empty or partially full.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

AffectedGas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
RiskLabeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: L...

Presence of particulate matter: a white thread-like structure in the cartridge

AffectedLiraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108...
RiskPresence of particulate matter: a white thread-like structure in the cartridge
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal...

Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.

AffectedMG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: P...
RiskMicrobial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

AffectedPrimidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 1913...
RiskCross contamination with other products: API contaminated with trace amounts of Acemetacin API.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Co...

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

AffectedPrimidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American...
RiskCross contamination with other products: API contaminated with trace amounts of Acemetacin API.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camaril...

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

AffectedPrimidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, I...
RiskCross contamination with other products: API contaminated with trace amounts of Acemetacin API.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syring...

Presence of a Foreign Substance; black particles observed in liquid

AffectedVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers...
RiskPresence of a Foreign Substance; black particles observed in liquid
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 4...

Crystallization; identified as Buprenorphine free base

AffectedBuprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malv...
RiskCrystallization; identified as Buprenorphine free base
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Ver...

Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.

AffectedOasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medic...
RiskLack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observatio...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x...

Lack of assurance of Sterility: potential product contamination

AffectedBD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36...
RiskLack of assurance of Sterility: potential product contamination
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2...

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

AffectedDELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only...
RiskLack of Assurance of Sterility: Potential leaks from perforations in bags.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona...

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

AffectedDuloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Mar...
RiskCGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules...

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

AffectedDuloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-...
RiskCGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the...
ActionNot available

Missing from associated official evidence: action.