Class II · Moderate risk
Chlorthalidone Tablets
Failed Dissolution Specifications
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 60631-425-30 Manufactured for Arbor Pharmaceuticals Atlanta, GA 30328
Affected NDC
60631-0425-30
Compare with the code on your package — it is the most precise check available.
Drug: Chlorthalidone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Edarbyclor Azilsartan kamedoxomil and chlorthalidone NDC 60631-0425 |
AZILSARTAN KAMEDOXOMIL 40 mg/1; CHLORTHALIDONE 25 mg/1 | Tablet Oral |
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | Rx |
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 60631-425-30
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0431-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Chlorthalidone recalls
See all
Class II · Moderate risk
Chlorthalidone Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Chlorthalidone Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Chlorthalidone Tablets USP 25 mg
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Class II · Moderate risk
CHLORTHALIDONE Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Other recalls by Cardinal Health Inc.
All 2021 recalls
Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.