The Recall Desk

FDA (Drugs) recall action 73925

Pharmedium Services, LLC recalled 69 products on 2016-10-19

The FDA (Drugs) publishes a recall like this one as 69 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 69 pages.

Products
69
Announced
2016-10-19
Critical
0
Units
296,748

Why these products were recalled

Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 69

  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Heparin Sodium Syringes Due to Subpotency and Stability Concerns

    Pharmedium Services, LLC is recalling 350 syringes of Heparin Sodium Injection USP because confirmed subpotency and stability data do not support the expiry date.

    Product
    HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Heparin Syringes Recalled Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 240 Heparin Sodium syringes because stability data does not support the expiry date, posing a risk of reduced drug potency.

    Product
    HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 USP Heparin Units per mL, Rx only, PharMEDium, Product code 2K1925.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Methadone Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 200 syringes of methadone HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6134.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Neostigmine Methylsulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 700 syringes of neostigmine methylsulfate because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3551.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Heparin Sodium Injections Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 399 syringes of Heparin Sodium Injection because stability data does not support the expiration dates, posing a risk of loss of potency.

    Product
    HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2K1210.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls ePHEDrine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 1,545 syringes of ePHEDrine Sulfate because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3347.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 21,506 syringes of morphine sulfate because stability data does not support the expiry dates, posing a risk of potency loss.

    Product
    morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 2 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3259.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Fentanyl Citrate Injection Due to Subpotency and Stability Issues

    Pharmedium Services, LLC is recalling specific lots of fentanyl citrate injection because confirmed subpotency and stability data do not support the expiry date.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Ketamine Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 25 syringes of ketamine HCl because stability data does not support the expiry date, posing a risk of reduced drug potency.

    Product
    ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3234.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Fentanyl Citrate Injection Recalled Due to Potential Loss of Potency

    Pharmedium Services is recalling fentanyl citrate injection syringes because stability data does not support the expiration date, posing a risk of reduced drug potency.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Product code 2R3118, NDC 61553-118-40
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 2,961 syringes of lidocaine HCl 1% because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3102.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 500 syringes of lidocaine HCl 1% because stability data does not support the expiry date, posing a risk of loss of potency.

    Product
    lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3104.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Buffered Lidocaine Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 660 syringes of Buffered Lidocaine because stability data does not support the expiry dates, posing a risk of potency loss.

    Product
    Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Ketamine HCl Injection Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 54 syringes of ketamine HCl injection because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a syringe, Rx only, PharMEDium, For IV Use, Product code 2R3500.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Rocuronium Bromide Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 6,970 syringes of rocuronium bromide because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Labetalol HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 969 syringes of labetalol HCl because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 25 syringes of morphine sulfate 2 mg/mL due to stability data that does not support the expiry date, posing a risk of potential loss of potency.

    Product
    morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6455.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2016-10-19

    Pharmedium Recalls Fentanyl Citrate Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 997 syringes of fentanyl citrate injection because stability data does not support the expiry date, posing a potential loss of potency.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 300 syringes of lidocaine HCl 1% because stability data does not support the expiry date, posing a potential loss of potency.

    Product
    lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3391.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Hydromorphone Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 1,916 syringes of Hydromorphone HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3162.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Fentanyl Citrate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 616 syringes of fentanyl citrate because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3424.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Hydromorphone Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 450 syringes of Hydromorphone HCl because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6165
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Glycopyrrolate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 17,462 syringes of glycopyrrolate because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3329.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Atropine Sulfate Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 5,568 syringes of atropine sulfate injection because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 935 syringes of morphine sulfate because stability data does not support the expiry dates, posing a risk of reduced potency.

    Product
    morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119.
    Category
    Distribution
    0 states