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Recall Observatory FDA recall evidence

Drug product

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.

D-1123-2019

March 22, 2019

Class II

Product summary

Firm
InvaGen Pharmaceuticals, Inc.
Event
Event 82463
Status
Terminated
Classification
Class II
Quantity
12234 vials
Official record key
drug-enforcement:D-1123-2019

Official wording

Reason: Presence of Particulate Matter.

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.

Distribution pattern: Nationwide in the U.S.A.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter