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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

Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. C...

Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test

AffectedEnalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratori...
RiskFailed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA...

Chemical contamination; presence of lead and lithium above specification

AffectedNAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals,...
RiskChemical contamination; presence of lead and lithium above specification
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg st...

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

AffectedOctreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8...
RiskLack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administrat...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection,...

Incorrect Product Formulation: product did not contain insulin as listed in the label.

AffectedTPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refr...
RiskIncorrect Product Formulation: product did not contain insulin as listed in the label.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc.,...

This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

AffectedAlendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharma...
RiskThis recall is being conducted due to out of specification assay results in a limited number of bottles that were sto...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC:...

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

AffectedGenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Te...
RiskLack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Wal...

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

AffectedSimilasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: T...
RiskLack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an insp...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60

Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

AffectedClaravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister pa...
RiskFailed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

AffectedDEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, ND...
RiskLack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

AffectedFurosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 070...
RiskCGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distrib...

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

AffectedOmega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only,...
RiskFailed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Dry...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Pis...

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

AffectedPantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharma...
RiskDiscoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighte...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth...

Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the b...

AffectedPremier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Ro...
RiskLabeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 i...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

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

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

AffectedCinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalgang...
RiskCGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
ActionNot available

Missing from associated official evidence: action.