Class I
Terminated
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
- Company
- Fabscout Entertainment, Inc
- Recall Initiated
- June 27, 2013
- Posted
- March 26, 2014
- Recall Number
- D-1169-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Ft Lauderdale, FL, United States
Reason for Recall
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
Distribution
Nationwide and France
Lot / Code Info
All lots
More recalls by Fabscout Entertainment, Inc
Other recent Class I Drug recalls
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactu...
Mckesson
· Feb 18, 2026
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLu...
Green Lumber Holdings, Llc
· Feb 11, 2026
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India...
Handelnine Global Llc
· Feb 11, 2026
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNat...
Medinatura New Mexico, Inc.
· Jan 14, 2026
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, L...
Fresenius Kabi Usa, Llc
· Dec 3, 2025