Status
Ongoing
Drug Enforcement D-0799-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Classification
Class II
Report Date
June 7, 2023
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- N/A
- Reason for recall
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Location & Firm
- Recalling firm
- Akorn, Inc.
- Address
-
5605 Centerpoint Ct Ste A, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0799-2023
- Event ID
- 91788
- Recall initiation date
- April 26, 2023
- Center classification date
- June 1, 2023
- Code info
- All Lots
- More code info
- —