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

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.

Subpotent Drug: confirmed subpotency in one lot of this product that was 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

  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Glycopyrrolate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 16,366 syringes of glycopyrrolate because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217.
    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 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 Ephedrine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 995 syringes of ePHEDrine Sulfate because stability data does not support the expiration dates, posing a risk of loss of potency.

    Product
    ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3301.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 3,159 syringes of lidocaine HCl 2% because stability data does not support the expiry date, posing a risk of reduced potency.

    Product
    lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3450.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Phenylephrine Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 498 syringes of Phenylephrine HCl because stability data does not support the expiry date, posing a risk of loss of potency.

    Product
    PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3109.
    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
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

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

    Product
    morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3353.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 110 syringes of fentanyl citrate because stability data does not support the expiry date, posing a risk of reduced drug potency.

    Product
    fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Lidocaine Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 4,400 syringes of lidocaine HCl 1% because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.
    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
  • 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

    Pharmedium Recalls Fentanyl Citrate Injection Syringes Due to Stability Concerns

    Pharmedium Services, LLC is recalling 53,357 syringes of fentanyl citrate injection because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3303.
    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 Remifentanil Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 1,623 syringes of remifentanil HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3300.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Neostigmine Methylsulfate Syringes Due to Stability Concerns

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

    Product
    neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550.
    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
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Neostigmine Methylsulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 2,105 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, 5 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3326.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency

    Pharmedium Services is recalling 8,955 syringes of fentanyl citrate because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Midazolam Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 26,079 syringes of midazolam HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Methadone Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 7,006 syringes of methadone HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Atropine Sulfate Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 4,407 syringes of atropine sulfate injection nationwide because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Fentanyl Syringes Due to Stability Data Concerns

    Pharmedium Services is recalling 1,561 syringes of fentanyl citrate because stability data does not support the expiry dates, posing a risk of potency loss.

    Product
    fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 3,270 syringes of morphine sulfate due to stability data that does not support the expiry date, posing a potential loss of potency.

    Product
    morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 1 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3017.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 830 syringes of lidocaine HCl, 2%, preservative-free, because stability data does not support the expiry dates, posing a risk of potential loss of potency.

    Product
    lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC 61553-323-79
    Category
    Distribution
    0 states