Recalls / Class II
Class IID-0611-2017
Product
Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun Pharma Ind. Inc., NJ 08512, Manufactured by Sun Pharma Ind. Ltd. India, NDC 62756-015-40
- Brand name
- Testosterone Cypionate
- Generic name
- Testosterone Cypionate
- Active ingredient
- Testosterone Cypionate
- Route
- Intramuscular
- NDCs
- 62756-015, 62756-017, 62756-016
- FDA application
- ANDA201720
- Affected lot / code info
- JKR0744A, JKR0745A, JKR0750A, JKR0795A; Exp. 09/18
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 83,188 single does vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-03-15
- FDA classified
- 2017-03-23
- Posted by FDA
- 2017-03-29
- Terminated
- 2018-04-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0611-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.