Drug and pharmaceutical recalls
17731 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Product code 2R3118, NDC 61553-118-40
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIFentanyl 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIePHEDrine 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIePHEDrine 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIePHEDrine 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIBuffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2475.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIBuffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIatropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIatropine 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugTeva Pharmaceuticals USAClass IIAmikacin 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).
CGMP Deviations
- 2016-10-19FDA-DrugTeva Pharmaceuticals USAClass IIAmikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
CGMP Deviations
- 2016-10-19FDA-DrugThe Harvard Drug GroupClass IDiocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
- 2016-10-19FDA-DrugBee XtremeClass IJenesis 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
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
- 2016-10-19FDA-DrugBee XtremeClass IOasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
- 2016-10-19FDA-DrugBee XtremeClass ILa' 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
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
- 2016-10-19FDA-DrugLeiter's CompoundingClass IIVancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IIPlacebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IIMoxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IIMitomycin 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
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IILidocaine HCl 1% - Phenylephrine HCl 1.5% 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 70360-002-35
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IICyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IICefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IIBrilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IIAtropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugAmerisource Health ServicesClass IIIParicalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
- 2016-10-12FDA-DrugWest-Ward PharmaceuticalClass IIPredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
- 2016-10-12FDA-DrugSun Pharmaceutical Industries, Inc.Class IIIbuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86
Failed Dissolution Specifications
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