Why it was recalled
Presence of Particulate Matter.
Product description
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.
Lot numbers, UPCs & expiration codes
Lots #: GH80216 Exp 1/2020; GH80322, GH80323 Exp 2/2020; GH90072 Exp 12/2020.
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-1125-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 22, 2019
- FDA report date
- Apr 24, 2019
- Quantity
- 75968 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1125-2019, 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
- Lots #: GH80216 Exp 1/2020; GH80322, GH80323 Exp 2/2020; GH90072 Exp 12/2020.
- Postal code
- 11722-4415
- Report date
- Apr 24, 2019
- Product type
- Drugs
- Recall number
- D-1125-2019
- Classification
- Class II
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- Product quantity
- 75968 vials
- Termination date
- Aug 16, 2022
- Reason for recall
- Presence of Particulate Matter.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the U.S.A.
- Recall initiation date
- Mar 22, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 15, 2019