← FDA ENFORCEMENT
D-0173-2024Class II
CARDINAL HEALTHCARE
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
CARDINAL HEALTHCARE
Product type
Drug
Status
Terminated
Report date
2024-01-03
Distribution
Nationwide USA
Firm state
OH
Product quantity
1 unit
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason for recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Product description
CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 0378-6232-01
Code / lot info
Batch 3131748
Other recalls SPEQ maps to Documentation & Change Control
2026-10-21Class IIIn2bones USA, LLC2026-10-21Class IIW L Gore & Associates, Inc.2026-10-21Class IIEthicon, LLC2026-10-21Class IIBoston Scientific Corporation
See all Documentation & Change Control recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →