Recalls / Class II
Class IID-1124-2019
Product
Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single 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 69097-537-31.
- 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
- Lot #:GH80009, GH80010, GH80011 Exp 12/2019; GH80568, GH80575, GH80579, GH80580, GH80581, GH80582 Exp 4/2020; GH80646, GH80664, GH80665, GH80684, GH80699, GH80700, GH80701, GH80746, GH80761, GH80765, GH80777 Exp 05/2020; GH80801, GH80823, GH80828, GH80878 Exp 06/2020; GH80967, GH80968, GH81033, GH81034 Exp 07/2020; GH81042, GH81154 Exp 08/2020; GH81255, GH81256, GH81288, GH81289, GH81310 Exp 10/2020 and GH81311 Exp 10/2020
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
- 692538 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-1124-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.