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.

26–50 of 69

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 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 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.
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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 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
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
ModerateFDA (Drugs)··2016-10-19
Pharmedium Recalls Midazolam HCl Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 4,058 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 (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product Code 2R3351.
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
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
ModerateFDA (Drugs)··2016-10-19
Pharmedium Recalls Glycopyrrolate Syringes Due to Insufficient Stability Data
Pharmedium Services, LLC is recalling specific lots of glycopyrrolate syringes because stability data does not support the expiration dates, posing a risk of reduced potency.
Product
glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3340.
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
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 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
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
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 Buffered Lidocaine Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 10 syringes of Buffered Lidocaine 2% because stability data does not support the expiry date, posing a risk of loss of potency.
Product
Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2475.
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.
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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
SevereFDA (Drugs)··2016-10-19
Pharmedium Recalls Midazolam Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 1,700 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, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196.
Category
Distribution
0 states
ModerateFDA (Drugs)··2016-10-19
Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 512 syringes of lidocaine HCl 2% because stability data does not support the expiry date, posing a potential loss of potency.
Product
lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3384.
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
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 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 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 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