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D-0175-2024Class 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
Reason for recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Product description

Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01

Code / lot info

Batch 3197790

Other recalls SPEQ maps to Documentation & Change Control
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 →