HOSPIRA INC, LAKE FOREST: Presence of Particulate Matter: Silicone oil

Agency Publication Date: August 9, 2017

Affected Products

Product: Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01

Lot #: 560053F, Exp. 01AUG2017

Lot Numbers:

560053F

Product: Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50

Lot #: 56260DD, Exp. 01AUG2017

Lot Numbers:

56260DD

Product: Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.

Lot #: 560103F, Exp. 01AUG2017

Lot Numbers:

560103F

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77836

Status: Resolved

Manufacturer: HOSPIRA INC, LAKE FOREST

Manufactured In: United States

Units Affected: 3 products (14,300 vials; 9,009 vials; 56,340 vials)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01

Lot #: 560053F, Exp. 01AUG2017

Lot Numbers:

560053F

Product: Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50

Lot #: 56260DD, Exp. 01AUG2017

Lot Numbers:

56260DD

Lot #: 560103F, Exp. 01AUG2017

Lot Numbers:

560103F