Why it was recalled
Presence of Particulate Matter.
Product description
Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 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 69097-537-37.
Lot numbers, UPCs & expiration codes
Lot #: GH80159, GH80160, GH80161 Exp 01/2020; GH80489, GH80490, GH80502, GH80503, GH80504 Exp 03/2020; GH80557, GH80598, GH80601, GH80602 Exp 04/2020; GH80845, GH80846, GH80855, GH80856, GH80857, GH80877 Exp 06/2020; GH80903, GH80908, GH80931 Exp 07/2020; GH81047 Exp 08/2020.
Where it was sold
Nationwide in the U.S.A.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1123-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 22, 2019
- FDA report date
- Apr 24, 2019
- Quantity
- 12234 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1123-2019, exactly as published.
Show all FDA fields
- City
- Central Islip
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 82463
- Address
- 550 S Research Pl
- Code information
- Lot #: GH80159, GH80160, GH80161 Exp 01/2020; GH80489, GH80490, GH80502, GH80503, GH80504 Exp 03/2020; GH80557, GH80598, GH80601, GH80602 Exp 04/2020; GH80845, GH80846, GH80855, GH80856, GH80857, GH80877 Exp 06/2020; GH80903, GH80908, GH80931 Exp 07/2020; GH81047 Exp 08/2020.
- Postal code
- 11722-4415
- Report date
- Apr 24, 2019
- Product type
- Drugs
- Recall number
- D-1123-2019
- Classification
- Class II
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- Product quantity
- 12234 vials
- Termination date
- Aug 16, 2022
- Reason for recall
- Presence of Particulate Matter.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 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 69097-537-37.
- Distribution pattern
- Nationwide in the U.S.A.
- Recall initiation date
- Mar 22, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 15, 2019