Drugs Recalls

17,415 recalls in this category

FDA Drug Class III Terminated

Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed

February 15, 2013 Warner Chilcott Company LLC 27,509 bottles units
FDA Drug Class III Terminated

Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed

February 15, 2013 Warner Chilcott Company LLC 6,408 bottles units
FDA Drug Class II Terminated

METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)

February 15, 2013 Hospira, Inc. 567,624 bags units
FDA Drug Class II Terminated

Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only, Dist. By: Dr. REDDY'S Laboratories, Inc., Bridgew

February 15, 2013 Dr Reddys Laboratories Tennessee LLC 4236 Bottles units
FDA Drug Class III Terminated

Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generi

February 13, 2013 Glenmark Generics Inc., USA 591,972 bottles units
FDA Drug Class III Terminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavi

February 13, 2013 Actavis Elizabeth LLC 9,264 Bottles units
FDA Drug Class II Terminated

ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharm

February 13, 2013 Watson Laboratories Inc 136,720 cartons units
FDA Drug Class I Terminated

MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL

February 12, 2013 OLAAX International 600 boxes units
FDA Drug Class II Terminated

0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08

February 12, 2013 Hospira, Inc. 56,854 Units units
FDA Drug Class II Terminated

Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury,

February 11, 2013 Jubilant Cadista Pharmaceuticals Inc. 12770 bottles units
FDA Drug Class II Terminated

Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01

February 8, 2013 Watson Laboratories Inc 20,587 bottles units
FDA Drug Class II Terminated

Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 9591-5239-01

February 8, 2013 Watson Laboratories Inc 9,824 bottles units
FDA Drug Class II Terminated

CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA PHARMACEUTICALS USA, Sellersville PA 18960, NDC #0555-0096-96

February 7, 2013 Teva Pharmaceuticals USA, Inc. 3 boxes units
FDA Drug Class II Terminated

Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntown, NJ 07724 by Hikma Pharmaceuticals, Amman, Jordan, NDC 0143-9928-01

February 6, 2013 West-ward Pharmaceutical Corp. 7,136 units units
FDA Drug Class II Terminated

Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP

February 4, 2013 Carib Import & Export, Inc. 480 bottles units
FDA Drug Class III Terminated

buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Dis

February 4, 2013 American Health Packaging 389 cartons units
FDA Drug Class III Terminated

TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics & Specialty Products Division of Teva Pharmaceuticals USA, Sellersville, PA 18960

February 1, 2013 Ferring Pharmaceuticals Inc 126 injectors units
FDA Drug Class III Terminated

CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, N

February 1, 2013 Fresenius Kabi USA LLC (FK USA) 155,900 vials domestically units
FDA Drug Class III Terminated

Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by

January 31, 2013 Lupin Pharmaceuticals Inc. 64,368 bottles units
FDA Drug Class I Terminated

Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, UPC 3 61958 01011 5; NDC 61958-0101-1.

January 31, 2013 Gilead Sciences, Inc. 3,181 vials units
FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC

January 31, 2013 Noven Pharmaceuticals, Inc. 335,910 patches units
FDA Drug Class II Terminated

ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16

January 30, 2013 TG United, Inc. 4811 - 16 ounce bottles. units
FDA Drug Class II Terminated

ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30

January 30, 2013 TG United, Inc. 39,801 - 30 mL bottles. units
FDA Drug Class II Terminated

BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737

January 30, 2013 TG United, Inc. 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce. units
FDA Drug Class II Terminated

CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30

January 30, 2013 TG United, Inc. 6551 30 mL bottles units
FDA Drug Class II Terminated

Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16

January 30, 2013 TG United, Inc. 12,120 - 16 ounce bottles units
FDA Drug Class II Terminated

Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01

January 30, 2013 TG United, Inc. 8296 bottles - 100-count and 153,028 Bulk tablets units
FDA Drug Class II Terminated

Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60

January 30, 2013 TG United, Inc. 978,092 Bulk Tablets units
FDA Drug Class II Terminated

Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16

January 30, 2013 TG United, Inc. 4,884 - 16 ounce bottles units
FDA Drug Class II Terminated

AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.

January 30, 2013 TG United, Inc. 348 - 16 ounce bottles. units
FDA Drug Class II Terminated

Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01

January 30, 2013 TG United, Inc. 2706 bottles of 100 count tablets units
FDA Drug Class II Terminated

AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0

January 30, 2013 TG United, Inc. 348 - 16 ounce bottles units
FDA Drug Class II Terminated

Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16

January 30, 2013 TG United, Inc. N/A units
FDA Drug Class II Terminated

ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01

January 30, 2013 TG United, Inc. 242,470 units
FDA Drug Class II Terminated

AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-

January 30, 2013 TG United, Inc. 348 - 16 ounce bottles units
FDA Drug Class II Terminated

Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16

January 30, 2013 TG United, Inc. 2388 - 16 ounce bottles. units
FDA Drug Class II Terminated

BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01

January 30, 2013 TG United, Inc. 16,836 bottles - 100-count. units
FDA Drug Class II Terminated

BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737

January 30, 2013 TG United, Inc. 57,936 bottles - 20 mL and 7,476 bottles -16 ounce units
FDA Drug Class II Terminated

Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30

January 30, 2013 TG United, Inc. 12,988 - 30 mL bottles. units
FDA Drug Class II Terminated

TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16

January 30, 2013 TG United, Inc. 98,202 16 ounce bottles. units
FDA Drug Class II Terminated

Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16

January 30, 2013 TG United, Inc. 12,198 - 16 ounce bottles. units
FDA Drug Class II Terminated

NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01

January 30, 2013 TG United, Inc. 4824 bottles - 100-count units
FDA Drug Class II Terminated

Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10

January 30, 2013 TG United, Inc. 2957 bottles 100-count tablets units
FDA Drug Class II Terminated

TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30

January 30, 2013 TG United, Inc. 13,031 30 mL bottles. units
FDA Drug Class II Terminated

AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16

January 30, 2013 TG United, Inc. 348 - 16 ounce bottles units
FDA Drug Class II Terminated

TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16

January 30, 2013 TG United, Inc. 2532 - 16 ounce bottles. units
FDA Drug Class II Terminated

Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30

January 30, 2013 TG United, Inc. 26,536 bottles - 30 mL units
FDA Drug Class II Terminated

Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05.

January 30, 2013 Mylan Pharmaceuticals Inc. 1,894 bottles units
FDA Drug Class II Terminated

Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30

January 30, 2013 TG United, Inc. 216,838 bottles - 30 mL units
FDA Drug Class II Terminated

AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.

January 30, 2013 TG United, Inc. 355 - 16 ounce bottles units

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