Brand
Azurity Pharmaceuticals, Inc.
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Azurity Pharmaceuticals, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-02-07FDA-DrugClass IZenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03
Labeling: Label Mix-up
- 2024-01-10FDA-DrugClass IIIEprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
- 2023-04-12FDA-DrugClass IITestosterone 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.
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
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