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.

26–50 of 69

  • 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 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
  • 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 Lidocaine Syringes Due to Stability Data Concerns

    PharMEDium is recalling 499 syringes of lidocaine HCl 2% because stability data does not support the expiry date, posing a potential loss of potency.

    Product
    lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Succinylcholine Chloride Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 2,495 syringes of succinylcholine chloride injection because stability data does not support the expiration dates, posing a risk of loss of potency.

    Product
    succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357.
    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 Hydromorphone Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 4,860 syringes of Hydromorphone HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3352.
    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 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
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Subpotent Fentanyl Citrate Syringes Nationwide

    Pharmedium Services, LLC is recalling 500 syringes of fentanyl citrate due to confirmed subpotency. The product was distributed nationwide.

    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 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 Fentanyl and Bupivacaine Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 210 syringes of Fentanyl Citrate and Bupivacaine HCl because stability data does not support the expiration dates, posing a risk of loss of potency.

    Product
    Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.
    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
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Lidocaine Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 3,285 syringes of lidocaine HCl because stability data does not support the expiry date, posing a risk of reduced drug potency.

    Product
    lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3140.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Pharmedium Recalls Methadone Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 7,556 syringes of methadone HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6149.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Phenylephrine Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling specific lots of Phenylephrine HCl syringes because stability data does not support the expiration dates, posing a risk of reduced drug 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 2R3346.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Ketamine HCl Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 12,173 syringes of ketamine HCl Injection because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3348.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-10-19

    Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 1,735 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, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3479.
    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
  • 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 Recalls ePHEDrine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 1,478 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, 50 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 2R3308.
    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
  • 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 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 Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 1,161 syringes of lidocaine HCl 2% because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product code 2R3441, NDC 61553-441-80
    Category
    Distribution
    0 states