Class II · Moderate risk Ongoing
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…
Reason shortfill; reports of empty capsules.
Is Dicyclomine recalled?
4 FDA recalls mention Dicyclomine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dicyclomine.
Class II · Moderate risk Ongoing
Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
DICYCLOMINE HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591079501.
Reason Labeling: Label Mixup: DICYCLOMINE HCL, Tablet, 20 mg may have potentially been mislabeled as the following drug: RAMIPRIL, Capsule, 2.5 mg, NDC…
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