Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40
Reported: August 1, 2018 Initiated: July 12, 2018 #D-0977-2018
Product Description
Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40
Reason for Recall
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 5215 units
- Distribution
- Nationwide within the United States
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 5215 units.
Why was this product recalled? ▼
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 1, 2018. Severity: Moderate. Recall number: D-0977-2018.
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