PlainRecalls

FDA Drug Safety

U.S. Food and Drug Administration — Drug recalls and safety communications

17,379 recalls · Page 165 of 348

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Moderate Jan 16, 2019

Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured b…

Glenmark Pharmaceuticals Inc., USA

Moderate Jan 16, 2019

Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : …

Heritage Pharmaceuticals, Inc.

Moderate Jan 16, 2019

Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pha…

Lupin Pharmaceuticals Inc.

Critical Jan 16, 2019

Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); R…

Lupin Pharmaceuticals Inc.

Critical Jan 16, 2019

Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceuti…

Sun Pharmaceutical Industries, Inc.

Critical Jan 16, 2019

Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); R…

Lupin Pharmaceuticals Inc.

Critical Jan 16, 2019

Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx o…

Lupin Pharmaceuticals Inc.

Critical Jan 16, 2019

Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc…

Lupin Pharmaceuticals Inc.

Moderate Jan 16, 2019

OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612…

Allergan, PLC.

Critical Jan 16, 2019

Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun Pharmaceutic…

Sun Pharmaceutical Industries, Inc.

Moderate Jan 16, 2019

0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffer…

PharMEDium Services, LLC.

Moderate Jan 16, 2019

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporati…

Baxter Healthcare Corporation

Moderate Jan 9, 2019

Methocarbamol liquid 100mg/ml, RX, glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Lidocaine gel 2%, RX, plastic dropper

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Glutathione liquid, 200mg/ml, Rx

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Lidocaine gel 1%, RX, plastic dropper

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

HCG liquid, 1000u/ml, RX, glass vial, various

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Testosteron Cypionate liquid 200mg/ml, RX, glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Cyclosporin liquid 0.2%, Rx, plastic dropper bottle

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured f…

LUPIN SOMERSET

Moderate Jan 9, 2019

Cyclosporin liquid 0.05%, Rx, plastic dropper bottle

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Vitamin B12 liquid 1000mcg/ml, RX, glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Glutathione liquid, 100mg/ml

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Epinephrine liquid 1:1000, RX, glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Cyclosporin liquid 1%, Rx, plastic dropper bottle

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Moderate Jan 9, 2019

Cyclosporin liquid 0.5%, Rx, plastic dropper bottle

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Critical Jan 2, 2019

Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe…

Advanced Pharma Inc.

Low Jan 2, 2019

Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmac…

Amerigen Pharmaceuticals Inc.

Low Jan 2, 2019

Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharma…

Amerigen Pharmaceuticals Inc.

Moderate Dec 26, 2018

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distribu…

Tris Pharma Inc.

Critical Dec 26, 2018

Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01

Asclemed USA Inc. dba Enovachem

Moderate Dec 26, 2018

Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intra…

Pharmedium Services, LLC

Low Dec 26, 2018

Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.

CBI Laboratories, Inc.

Moderate Dec 26, 2018

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bo…

Tris Pharma Inc.

Moderate Dec 26, 2018

Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10

Pharm D Solutions, LLC

Moderate Dec 26, 2018

Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-…

Pfizer Inc.

Moderate Dec 26, 2018

Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE Healthcare Inc.…

GE Healthcare Inc. Life Sciences

Critical Dec 26, 2018

Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01

Asclemed USA Inc. dba Enovachem

Low Dec 26, 2018

Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. H…

Sun Pharmaceutical Industries, Inc.

Critical Dec 26, 2018

Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S…

Results RNA, LLC

Moderate Dec 26, 2018

Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01

Epic Pharma, LLC

Moderate Dec 26, 2018

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) b…

Tris Pharma Inc.

Moderate Dec 26, 2018

Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50

KVK-Tech, Inc.

Moderate Dec 26, 2018

Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc.…

Cipla Limited

Moderate Dec 26, 2018

Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syrin…

Pharmedium Services, LLC

Low Dec 26, 2018

NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per ca…

VistaPharm, Inc.