Azurity Pharmaceuticals

4 recalls •

💊 Drugs

• Categories: Prescription Drugs

Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03

Class I - Dangerous

Labeling: Label Mix-up

Jan 4, 2024 Prescription Drugs Nationwide View Details →

Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.

Dec 8, 2023 Prescription Drugs Nationwide View Details →

Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.

Class I - Dangerous

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Feb 15, 2023 Prescription Drugs Nationwide View Details →

Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05.

Class I - Dangerous

Product Mix-up: Incorrect diluent component included in the kit.

Aug 24, 2021 Prescription Drugs Nationwide View Details →