Dicyclomine Hydrochloride Injectable Drug Recalled for Manufacturing Quality Deviations
Akorn, Inc. is recalling all lots of Dicyclomine Hydrochloride Injection USP nationwide due to Current Good Manufacturing Practice deviations. The firm went out of business and could not complete required stability studies.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall involving manufacturing quality deviations and incomplete stability verification. No illnesses, adverse events, or deaths are reported. The hazard is theoretical rather than a confirmed product defect.
Plain-English summary
Akorn, Inc. is recalling all lots of Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL ampules. The product is a prescription injectable medication distributed nationwide in the USA and Puerto Rico by Akorn Operating Company, LLC, based in Gurnee, Illinois.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The firm went out of business and could no longer continue the stability studies required for pharmaceutical products. Stability testing verifies that a drug maintains its safety and effectiveness over its shelf life.
All lots of this product are included in the recall, which has been classified by the FDA as a Class II recall.
The recalled product
- Product
- Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Injectables
- Hazard
- manufacturing-deviation
- stability-unverified
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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