Prescription medicine recalls

Imprimis NJOF, LLC — Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1

Presence of particulate matter - Glass like particles.

Imprimis NJOF, LLC — Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.

Presence of particulate matter - Glass like particles.

CareFusion 213, LLC — BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29

Lack of Assurance of Sterlity

Alembic Pharmaceuticals Limited — Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

NOVADOZ PHARMACEUTICALS LLC — Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only

Failed Impurities/Degradation Specifications

Merck Sharp & Dohme LLC — Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only

Presence of particulate matter: potential presence of metal particulates in the product.

Merck Sharp & Dohme LLC — Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only

Presence of particulate matter: potential presence of metal particulates in the product.

SOMERSET THERAPEUTICS LLC — Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only

Subpotent product:out of specification assay results observed during long term stability testing.

SUN PHARMACEUTICAL INDUSTRIES INC — Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc.

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

SOMERSET THERAPEUTICS LLC — Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only

Subpotent product:out of specification assay results observed during long term stability testing.

Winder Laboratories, LLC — Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

Golden State Medical Supply Inc. — Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only

Presence of Foreign Tablets/Capsules

SOMERSET THERAPEUTICS LLC — Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only

Subpotent product:out of specification assay results observed during long term stability testing.

Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only

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

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only

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

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Glenmark Pharmaceuticals Inc., USA — Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Fagron Compounding Services — Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St

Incorrect Product Formulation

Glenmark Pharmaceuticals Inc., USA — Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only

Cross Contamination with Other Products

Preferred Pharmaceuticals, Inc. — Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…

Cipla USA, Inc. — Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.