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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 12881–12900 of 17,816 recalls

Class ITerminated

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.

Pharmedium Services, LLC

Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IITerminated

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.

Pharmedium Services, LLC

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

July 17, 2015 · DrugView details →

Class IIITerminated

Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01

Mutual Pharmaceutical Company, Inc.

Chemical Contamination; benzophenone leached from the product label varnish

July 16, 2015 · DrugView details →

Class IIITerminated

Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01

Mutual Pharmaceutical Company, Inc.

Chemical Contamination; benzophenone leached from the product label varnish

July 16, 2015 · DrugView details →

Class IIITerminated

Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01

Mutual Pharmaceutical Company, Inc.

Chemical Contamination; benzophenone leached from the product label varnish

July 16, 2015 · DrugView details →

Class IITerminated

Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.

Safecor Health, LLC

Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.

July 16, 2015 · DrugView details →

Class IIITerminated

Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01

Mutual Pharmaceutical Company, Inc.

Chemical Contamination; benzophenone leached from the product label varnish

July 16, 2015 · DrugView details →

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