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.
Check against the official notice below — it lists the full affected range.
InvaGen Pharmaceuticals, Inc. has recalled testosterone cypionate injection (200 mg/mL) manufactured by Cipla Ltd. due to the presence of particulate matter in the medication. The recalled product is a 2000 mg/10 mL vial intended for intramuscular use, and the recall affects approximately 12,234 vials distributed nationwide in the United States across multiple lot numbers with expiration dates ranging from January 2020 through August 2020.
The specific lot numbers included in this recall are: GH80159, GH80160, GH80161, GH80489, GH80490, GH80502, GH80503, GH80504, GH80557, GH80598, GH80601, GH80602, GH80845, GH80846, GH80855, GH80856, GH80857, GH80877, GH80903, GH80908, GH80931, and GH81047. The source document does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Presence of Particulate Matter.
Reason for recall: Presence of Particulate Matter. Distribution: Nationwide in the U.S.A. Quantity: 12234 vials Lot/code info: 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.