Recalls / Class II
Class IID-1125-2019
Product
Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-536-37.
- Brand name
- Testosterone Cypionate
- Generic name
- Testosterone Cypionate
- Active ingredient
- Testosterone Cypionate
- Route
- Intramuscular
- NDCs
- 69097-536, 69097-537
- FDA application
- ANDA210362
- Affected lot / code info
- Lots #: GH80216 Exp 1/2020; GH80322, GH80323 Exp 2/2020; GH90072 Exp 12/2020.
Why it was recalled
Presence of Particulate Matter.
Recalling firm
- Firm
- InvaGen Pharmaceuticals, Inc.
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 550 S Research Pl, N/A, Central Islip, New York 11722-4415
Distribution
- Quantity
- 75968 vials
- Distribution pattern
- Nationwide in the U.S.A.
Timeline
- Recall initiated
- 2019-03-22
- FDA classified
- 2019-04-15
- Posted by FDA
- 2019-04-24
- Terminated
- 2022-08-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1125-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.