FDA Recall D-0893-2023
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · La Vergne, TN
Class I — life-threatening Terminated 398 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08
Reason for recall
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
Recall record
- Recall number
D-0893-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2023-05-31
- Classified by FDA Center
- 2023-07-05
- FDA published
- 2023-06-28
- Terminated
- 2024-07-02
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Firm location
- La Vergne, TN
Drug identification
- Brand name(s)
- ZIPRASIDONE
- Generic name(s)
- ZIPRASIDONE
- Manufacturer(s)
- Major Pharmaceuticals
- NDC(s)
0904-6269, 0904-6270, 0904-6271, 0904-6272- Route(s)
- ORAL