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