FDA Drug Class II — Moderate

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

Hazard

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

Products

Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01
Brand
CARDINAL HEALTHCARE
UPC
Batch 3197790

Units Affected

1 unit