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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

Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mf...

Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.

AffectedDesmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario,...
RiskDefective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro P...

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

AffectedFluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1...
RiskFailed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted dur...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC,...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

AffectedMGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medi...
RiskThis recall is being initiated following FDA's recommendation based on certain observations noted during an August 15...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen Internatio...

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

AffectedLanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: P...
RiskLack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in thei...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 6722...

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

AffectedVancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St....
RiskLack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA,...

Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.

AffectedBromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedmins...
RiskFailed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability t...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufa...

Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.

AffectedMagnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV b...
RiskProduct mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by:...

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

AffectedPrazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, N...
RiskcGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 3822...

Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).

AffectedtraMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt....
RiskFailed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the spec...
ActionNot available

Missing from associated official evidence: action.