Wilmington, MA, United States
Azurity Pharmaceuticals, Inc. recalls
4 recalls recorded since 2018, most recently on 4 January 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)2
Terminated Class I Drugs
- Recall started
- 4 January 2024
- Terminated
- 18 September 2024
- Reason
- Labeling: Label Mix-up
- Distribution
- USA nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0323-2024
- 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
Terminated Class III Drugs
- Recall started
- 8 December 2023
- Terminated
- 24 April 2024
- Reason
- Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0213-2024
- Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Terminated Class II Drugs
- Recall started
- 15 February 2023
- Terminated
- 4 December 2023
- Reason
- cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0489-2023
- 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., Atl
Terminated Class I Drugs
- Recall started
- 24 August 2021
- Terminated
- 12 May 2022
- Reason
- Product Mix-up: Incorrect diluent component included in the kit.
- Distribution
- USA nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0003-2022
- 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 Flav
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.