Pharmedium Services, LLC: Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

Agency Publication Date: September 23, 2015

Affected Products

Product: PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-171-50

Lot #: 14310039S, Exp 11/06/14; 14318006S, Exp 11/17/14; 14321060S, Exp11/07/14

Lot Numbers:

14310039S

Product: PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-169-50

Lot #: 14309095S, Exp 02/03/15; 14311008S, Exp 02/05/15

Lot Numbers:

14309095S

Product: Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50

Lot #: 143140080M, Exp 02/09/15; 143210133M, Exp 02/16/15; 143490031M, Exp 03/16/15

Lot Numbers:

143140080M

Product: Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-181-50

Lot #: 14308162M, Exp 02/02/15; 143130049M, Exp 02/08/15; 143220039M, Exp 02/16/15; 143490058M, Exp 03/16/15; 143560029M, Exp 03/23/15

Lot Numbers:

14308162M

Product: Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-107-50

Lot #: 14303122M, Exp 01/28/15; 14309029M, Exp 02/02/15; 14315067M, Exp 02/09/15; 14317040M, Exp 02/11/15; 14318026M, Exp 02/12/15; 14323089M, Exp 02/17/15; 14325128M, 14325124M, Exp 02/19/15

Lot Numbers:

14303122M

Product: PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-156-50

Lot #: 14310063S, Exp 02/04/15; 14316086S, Exp 02/10/15; 14322138S, Exp 02/16/15

Lot Numbers:

14310063S

Product: PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (240 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-236-50

Lot #: 14317035S, Exp 02/11/15

Lot Numbers:

14317035S

Product: PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-149-50

Lot #: 14308086S, Exp 02/02/15; 14309051S, Exp 02/03/15

Lot Numbers:

14308086S

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71844

Status: Resolved

Manufacturer: Pharmedium Services, LLC

Manufactured In: United States

Units Affected: 8 products (240 bags; 24 bags; 20 bags; 100 bags; 663 bags; 84 bags; 48 bags; 120 bags)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot #: 14310039S, Exp 11/06/14; 14318006S, Exp 11/17/14; 14321060S, Exp11/07/14

Lot Numbers:

14310039S

Lot #: 14309095S, Exp 02/03/15; 14311008S, Exp 02/05/15

Lot Numbers:

14309095S

Lot #: 143140080M, Exp 02/09/15; 143210133M, Exp 02/16/15; 143490031M, Exp 03/16/15

Lot Numbers:

143140080M

Lot #: 14308162M, Exp 02/02/15; 143130049M, Exp 02/08/15; 143220039M, Exp 02/16/15; 143490058M, Exp 03/16/15; 143560029M, Exp 03/23/15

Lot Numbers:

14308162M

Lot #: 14303122M, Exp 01/28/15; 14309029M, Exp 02/02/15; 14315067M, Exp 02/09/15; 14317040M, Exp 02/11/15; 14318026M, Exp 02/12/15; 14323089M, Exp 02/17/15; 14325128M, 14325124M, Exp 02/19/15

Lot Numbers:

14303122M

Lot #: 14310063S, Exp 02/04/15; 14316086S, Exp 02/10/15; 14322138S, Exp 02/16/15

Lot Numbers:

14310063S

Lot #: 14317035S, Exp 02/11/15

Lot Numbers:

14317035S

Lot #: 14308086S, Exp 02/02/15; 14309051S, Exp 02/03/15

Lot Numbers:

14308086S