Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharma
Summary
The FDA issued a Class II for Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healt by Preferred Pharmaceuticals, Inc.. Reason: Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack t.
Details
Source
Drug Recall
External ID
D-0173-2023
Action Date
2023-02-01
Status
Terminated
Category
drug
Product Description
Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharmaceuticals, Inc., The Physician's Solution, Prod#: 68788-7383-09.
Lot/Code Info: Lot: K3022Q, Expiration date: 3/31/2025
Quantity Affected: 9 bottles
Reason for Recall
Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Distribution
IN
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-16
Company
Anaheim, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Preferred Pharmaceuticals, Inc. has 36 FDA actions in our database, including 36 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Preferred Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Preferred Pharmaceuticals, Inc. have FDA actions?
Preferred Pharmaceuticals, Inc. has 36 FDA actions in our database, including 36 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0173-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for drugRelated Actions
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef
ProRx LLC · 2025-11-05
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU IN
Perrigo Company PLC · 2022-03-02
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 8826
Little Moon Essentials LLC · 2024-07-10
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
CARDINAL HEALTHCARE · 2024-01-03
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 6
Sentara Infusion Services · 2023-02-22