PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 3, 2024 Initiated: January 26, 2022 #D-0175-2024

Product Description

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

Reason for Recall

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

Details

Recalling Firm
CARDINAL HEALTHCARE
Units Affected
1 unit
Distribution
Nationwide USA
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01. Recalled by CARDINAL HEALTHCARE. Units affected: 1 unit.
Why was this product recalled?
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 3, 2024. Severity: Moderate. Recall number: D-0175-2024.