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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

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

Class I - Dangerous

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

Jul 17, 2015 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jul 17, 2015 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jul 17, 2015 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jul 17, 2015 Prescription Drugs Nationwide View Details →

Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.

Hospira Inc., A Pfizer Company

Class I - Dangerous

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Sep 16, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jul 17, 2015 Prescription Drugs Nationwide View Details →

mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.

Sep 13, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jul 17, 2015 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jul 17, 2015 Prescription Drugs Nationwide View Details →

Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA

Bee Xtreme

Class I - Dangerous

Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein

Dec 23, 2015 Prescription Drugs View Details →

Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35

Leiter's Compounding

Class I - Dangerous

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Sep 20, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jul 17, 2015 Prescription Drugs Nationwide View Details →

TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159.

Allergan Sales

Class I - Dangerous

Failed Content Uniformity Specifications

Jun 30, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jul 17, 2015 Prescription Drugs Nationwide View Details →

La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA

Bee Xtreme

Class I - Dangerous

Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein

Dec 23, 2015 Prescription Drugs View Details →

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

Class I - Dangerous

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

Jul 17, 2015 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jul 17, 2015 Prescription Drugs Nationwide View Details →

Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).

Teva Pharmaceuticals USA

Class I - Dangerous

CGMP Deviations

Jul 29, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jul 17, 2015 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jul 17, 2015 Prescription Drugs Nationwide View Details →