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.

51–69 of 69

  • 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 Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 499 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), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3106.
    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
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 592 syringes of morphine sulfate because stability data does not support the expiry date, posing a risk of loss of potency.

    Product
    morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3181.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Fentanyl Citrate Syringes Due to Stability Data Concerns

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

    Product
    fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a 3 mL BD Syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6107.
    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
  • 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
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 1,522 syringes of fentanyl citrate because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318.
    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
  • 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
  • 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
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Ketamine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 1,500 syringes of ketamine HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3320.
    Category
    Distribution
    0 states
  • 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 5,900 syringes of lidocaine HCl 1% because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Phenylephrine Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 380 syringes of Phenylephrine HCl because stability data does not support the expiry date, posing a potential loss of potency.

    Product
    PHENYLephrine HCl, 40 mcg per mL, 200 mcg 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 2R3376.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Ketamine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 9,101 syringes of ketamine HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3330.
    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
  • 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 Lidocaine Syringes Recalled for Potential Loss of Potency

    PharMEDium is recalling lidocaine HCl syringes because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3112.
    Category
    Distribution
    0 states