Drugs Recalls
17,415 recalls in this category
FDA Drug
Class II
Terminated
AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
January 30, 2013
TG United, Inc.
1772 bottles per 100 count each units
FDA Drug
Class II
Terminated
BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16
January 30, 2013
TG United, Inc.
22,721 - 16 ounce bottles units
FDA Drug
Class II
Terminated
TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10
January 30, 2013
TG United, Inc.
386 - 1000-count bottles units
FDA Drug
Class II
Terminated
Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30
January 30, 2013
TG United, Inc.
39,403 - 30 mL bottles units
FDA Drug
Class II
Terminated
Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01
January 30, 2013
TG United, Inc.
1623 bottles of 100-count tablets. units
FDA Drug
Class II
Terminated
Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60
January 30, 2013
TG United, Inc.
977,719 Bulk Tablets units
FDA Drug
Class II
Terminated
AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04
January 30, 2013
TG United, Inc.
1398 - 4 ounce bottles units
FDA Drug
Class II
Terminated
BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
January 30, 2013
TG United, Inc.
10,036 bottles - 100-count tablets units
FDA Drug
Class II
Terminated
AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, 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
AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16
January 30, 2013
TG United, Inc.
348 - 16 ounce bottles. units
FDA Drug
Class II
Terminated
Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30
January 30, 2013
TG United, Inc.
40,149 - 30 mL bottles. units
FDA Drug
Class II
Terminated
AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0226-16
January 30, 2013
TG United, Inc.
352 - 16 ounce bottles units
FDA Drug
Class II
Terminated
Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01
January 30, 2013
TG United, Inc.
330158 Bulk tablets. units
FDA Drug
Class II
Terminated
CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30
January 30, 2013
TG United, Inc.
26,315 - 30 mL bottles. units
FDA Drug
Class II
Terminated
AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
January 30, 2013
TG United, Inc.
886 bottles - 100-count tablets units
FDA Drug
Class II
Terminated
Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01
January 30, 2013
TG United, Inc.
31,739 bottles 100-count; 842,617 Bulk tablet bottles units
FDA Drug
Class III
Terminated
Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp., Eatontown, NJ 07724, Packaged and Distributed by: Stat Rx USA, NDC 42549-521-90.
January 28, 2013
Stat Rx USA
3 bottles units
FDA Drug
Class I
Terminated
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA; NDC 0409-7929-09.
January 25, 2013
Hospira, Inc.
143,136 flexible containers units
FDA Drug
Class II
Terminated
Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd.
January 23, 2013
Teva Pharmaceuticals USA, Inc.
3,913 bottles units
FDA Drug
Class III
Terminated
Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz),Dist. by Procter & Gamble, Cincinnati, OH 45202 NDC 37000-452-02
January 23, 2013
Procter & Gamble Hair Care Llc
71,040 bottles units
FDA Drug
Class III
Terminated
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
January 23, 2013
Mission Pharmacal Co
8,437 bottles units
FDA Drug
Class III
Terminated
Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Prince
January 22, 2013
Sandoz Incorporated
17,188 cartons containing 3 cards each. units
FDA Drug
Class II
Terminated
Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx
January 22, 2013
RX South LLC DBA RX3 Pharmacy
126 vials units
FDA Drug
Class II
Terminated
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
January 22, 2013
Fresenius Kabi USA LLC (FK USA)
23,672 vials units
FDA Drug
Class III
Terminated
Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distribu
January 18, 2013
Aaron Industries Inc
6,108 bottles (509 cases) units
FDA Drug
Class III
Terminated
Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03
January 18, 2013
Aaron Industries Inc
43,464 bottles (3,622 cases) units
FDA Drug
Class III
Terminated
Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (
January 18, 2013
Aaron Industries Inc
35,652 bottles (2,971 cases) units
FDA Drug
Class III
Terminated
Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-
January 18, 2013
Aaron Industries Inc
5,676 bottles (473 cases) units
FDA Drug
Class II
Terminated
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Active Ingredients Benzalkonium chloride 0.13% - Fir
January 17, 2013
Humco Holding Group, Inc
1,269,846 bottles units
FDA Drug
Class II
Terminated
Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.
January 16, 2013
Mylan Pharmaceuticals Inc.
11,580 bottles units
FDA Drug
Class III
Terminated
Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco,
January 16, 2013
Actelion Pharmaceuticals U.S., Inc.
3 Cartons units
FDA Drug
Class III
Terminated
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
January 11, 2013
AstraZeneca LP
64675 cartons units
FDA Drug
Class III
Terminated
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
January 11, 2013
AstraZeneca LP
28,476 cartons units
FDA Drug
Class II
Terminated
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
January 10, 2013
Hospira, Inc.
63,900 vials units
FDA Drug
Class II
Terminated
0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
January 8, 2013
Hospira, Inc.
325,056 bags units
FDA Drug
Class II
Terminated
Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets p
January 7, 2013
West-ward Pharmaceutical Corp.
6,511 bottles units
FDA Drug
Class III
Terminated
Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01.
January 7, 2013
West-ward Pharmaceutical Corp.
1,185 Bottles units
FDA Drug
Class I
Terminated
Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.
January 4, 2013
Reumofan Plus USA
586 bottles units
FDA Drug
Class III
Terminated
buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: Americ
January 4, 2013
Actavis Pharmaceuticals
14,856 bottles units
FDA Drug
Class I
Terminated
Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenu
January 3, 2013
Mobius Therapeutics LLC
83 boxes units
FDA Drug
Class II
Terminated
HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03
December 28, 2012
Hillyard GMP
2,139 bottles units
FDA Drug
Class I
Terminated
Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013
December 28, 2012
Advance Pharmaceutical Inc
19,944 bottles units
FDA Drug
Class III
Terminated
Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28; b) 385 g bottle, NDC 10631-099-38; Rx only, Ranbaxy, Jacksonville, FL 32257 USA.
December 27, 2012
Ranbaxy Inc.
6,535 tubes and bottles units
FDA Drug
Class III
Terminated
Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.
December 27, 2012
Ranbaxy Inc.
4,016 bottles units
FDA Drug
Class I
Terminated
Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9.
December 22, 2012
D& S Herbals, LLC
40,480 blister packs units
FDA Drug
Class III
Terminated
Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
December 21, 2012
Warner Chilcott Company LLC
5439 bottles units
FDA Drug
Class III
Terminated
Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
December 21, 2012
Warner Chilcott Company LLC
3155 bottles units
FDA Drug
Class II
Terminated
12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Proudly Distributed By: Valu Merchandisers, Co., Kansas City, MO
December 21, 2012
Lee Pharmaceuticals, Inc
32,460 bottles units
FDA Drug
Class I
Terminated
SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.
December 19, 2012
P & J Trading Co
unknown units
FDA Drug
Class II
Terminated
Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson
December 18, 2012
Watson Pharmaceuticals
3,040 bottles units