InvaGen Pharmaceuticals, Inc.: Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipl

Is my product affected?

Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single 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 69097-537-31.

• Brand TESTOSTERONE CYPIONATE

Check against the official notice below — it lists the full affected range.

What happened

InvaGen Pharmaceuticals, Inc. is recalling Testosterone Cypionate Injection, USP, 200 mg/mL in 1 mL vials manufactured by Cipla Ltd. in Verna, Goa, India. The recall affects approximately 692,538 vials distributed nationwide in the United States due to the presence of particulate matter in the product. The recall includes multiple lot numbers with expiration dates ranging from December 2019 through October 2020.

The affected lot numbers are: GH80009, GH80010, GH80011 (Exp 12/2019); GH80568, GH80575, GH80579, GH80580, GH80581, GH80582 (Exp 4/2020); GH80646, GH80664, GH80665, GH80684, GH80699, GH80700, GH80701, GH80746, GH80761, GH80765, GH80777 (Exp 05/2020); GH80801, GH80823, GH80828, GH80878 (Exp 06/2020); GH80967, GH80968, GH81033, GH81034 (Exp 07/2020); GH81042, GH81154 (Exp 08/2020); and GH81255, GH81256, GH81288, GH81289, GH81310, GH81311 (Exp 10/2020). The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Presence of Particulate Matter.

Details from the source

Reason for recall: Presence of Particulate Matter. Distribution: Nationwide in the U.S.A. Quantity: 692538 vials Lot/code info: Lot #:GH80009, GH80010, GH80011 Exp 12/2019; GH80568, GH80575, GH80579, GH80580, GH80581, GH80582 Exp 4/2020; GH80646, GH80664, GH80665, GH80684, GH80699, GH80700, GH80701, GH80746, GH80761, GH80765, GH80777 Exp 05/2020; GH80801, GH80823, GH80828, GH80878 Exp 06/2020; GH80967, GH80968, GH81033, GH81034 Exp 07/2020; GH81042, GH81154 Exp 08/2020; GH81255, GH81256, GH81288, GH81289, GH81310 Exp 10/2020 and GH81311 Exp 10/2020

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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