Recalls / Class I
Class ID-0893-2023
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Ziprasidone
- Generic name
- Ziprasidone
- Active ingredient
- Ziprasidone Hydrochloride
- Route
- Oral
- NDCs
- 0904-6269, 0904-6270, 0904-6271, 0904-6272
- FDA application
- ANDA077565
- Affected lot / code info
- Lot: T04769 Exp. 2024/12
Why it was recalled
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.
Recalling firm
- Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-05-31
- FDA classified
- 2023-07-05
- Posted by FDA
- 2023-06-28
- Terminated
- 2024-07-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0893-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.