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.
Reported: April 24, 2019 Initiated: March 22, 2019 #D-1125-2019
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.
Reason for Recall
Presence of Particulate Matter.
Details
- Recalling Firm
- InvaGen Pharmaceuticals, Inc.
- Units Affected
- 75968 vials
- Distribution
- Nationwide in the U.S.A.
- Location
- Central Islip, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by InvaGen Pharmaceuticals, Inc.. Units affected: 75968 vials.
Why was this product recalled? ▼
Presence of Particulate Matter.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 24, 2019. Severity: Moderate. Recall number: D-1125-2019.
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