FDA Recall Terminated Historical recordClass II
TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
Cardinal Health Inc.
Recalls
A bar chart of the number of recalls naming this company by year.
| Year | Recalls |
|---|---|
| 2021 | 86 |
| 2022 | 3 |
| 2023 | 6 |
| 2025 | 5 |
FDA Recall Terminated Historical recordClass II
LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
FDA Recall Terminated Historical recordClass II
ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
FDA Recall Terminated Historical recordClass II
ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
FDA Recall Terminated Historical recordClass II
Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
FDA Recall Terminated Historical recordClass II
IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS)
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
FDA Recall Terminated Historical recordClass II
xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
FDA Recall Terminated Historical recordClass II
xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
FDA Recall Terminated Historical recordClass II
Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
FDA Recall Terminated Historical recordClass II
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
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
FDA Recall Terminated Historical recordClass II
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
FDA Recall Terminated Historical recordClass II
Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
This page lists recalls that name Cardinal Health Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.
