Prescription medicine recalls

Boothwyn Pharmacy LLC — Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy

Subpotent Drug

Ascend Laboratories, LLC — Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Imprimis NJOF, LLC — Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01

Sub-Potent Drug: Subpotent assay results during stability testing.

Imprimis NJOF, LLC — Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733

Sub-Potent Drug: Subpotent assay results during stability testing.

Ascend Laboratories, LLC — Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Strides Pharma, Inc. — Cinacalcet Tablets 90 mg, 30-count bottles, Rx only

Failed Dissolution Specifications.

Boothwyn Pharmacy LLC — Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy

Subpotent Drug

Boothwyn Pharmacy LLC — Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496

Subpotent Drug

MEDLINE INDUSTRIES, LP - Northfield — H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

MEDLINE INDUSTRIES, LP - Northfield — Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

MEDLINE INDUSTRIES, LP - Northfield — CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

MEDLINE INDUSTRIES, LP - Northfield — ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

MEDLINE INDUSTRIES, LP - Northfield — Good Neighbor Pharmacy, Alcohol Prep Pads

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

MEDLINE INDUSTRIES, LP - Northfield — RITE AID PHARMACY, first aid alcohol prep pads

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

FDC Limited — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

Lupin Pharmaceuticals Inc. — Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles — PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmac

Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently…

Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim 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.

Dr. Reddy's Laboratories, Inc. — Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Cipla USA, Inc. — Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.