Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-918-2013 | 03-11-2013 | Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA | Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 2190 syringes | Class II | Terminated |
| D-208-2013 | 03-07-2013 | Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health / 91,872/1-oz. tubes and 94,464/2-oz. tubes | Class III | Terminated |
| D-841-2013 | 03-07-2013 | Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30 | Subpotent drug: low fill volume in some of the capsules | Sanofi US / 2,462 bottles | Class II | Terminated |
| D-207-2013 | 03-07-2013 | Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054. | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health / 240,120/2-oz. tubes and 429,144/4-oz. tubes | Class III | Terminated |
| D-210-2013 | 03-07-2013 | 4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health / 44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. bottles | Class III | Terminated |
| D-211-2013 | 03-07-2013 | 4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health / 227,124 bottles | Class III | Terminated |
| D-209-2013 | 03-07-2013 | 4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. Package NDCs: 0067-2086-01; 0067-2086-05; 0067-2086-15 | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health / 538,092/.5-fl. oz. bottles, 1,186,740/1-oz. bottles, and 138,528/1.25-fl. oz bottles | Class III | Terminated |
| D-202-2013 | 03-05-2013 | Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01. Package NDCs: 68382-018-06; 68382-018-14; 68382-018-16; 68382-018-01; 68382-018-05; 68382-018-10; 68382-019-06; 68382-019-14; 68382-019-16; 68382-019-01; 68382-019-05; 68382-019-10; 68382-020-06; 68382-020-14; 68382-020-16; 68382-020-01; 68382-020-05; 68382-020-10; 68382-021-06; 68382-021-14; 68382-021-16; 68382-021-01; 68382-021-05; 68382-021-10; 68382-101-06; 68382-101-14; 68382-101-16; 68382-101-01; 68382-101-05; 68382-101-10 | Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle. | Zydus Pharmaceuticals USA Inc / 13,320 bottles | Class II | Terminated |
| D-226-2013 | 03-04-2013 | SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, CareFusion, Leawood, KS 66211, Cat. No 260286, NDC 54365-145-01; and b) 3000-count applicators per case, Cat. No 260681, CareFusion, Leawood, KS 66211. | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. | CareFusion 213, LLC / 8,960,000 applicators | Class II | Terminated |
| D-229-2013 | 03-04-2013 | FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, CareFusion, Leawood, KS 66211. | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. | CareFusion 213, LLC / 544,500 kits | Class II | Terminated |
| D-227-2013 | 03-04-2013 | Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260307, NDC 54365-200-99, CareFusion, Leawood, KS 66211. | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. | CareFusion 213, LLC / 929,000 kits | Class II | Terminated |
| D-225-2013 | 03-04-2013 | SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, NDC 54365-161-01, CareFusion, Leawood, KS 66211; b) 3000-count applicators (Net 0.67 mL each) per case, Cat. No 260431, NDC 54365-151-01, CareFusion, Leawood, KS 66211; and c) 3000-count applicators (Net 0.67 mL each) per case, Reorder TA6200, Manufactured for: Tri-State Hospital Supply Corporation, Howell, MI 48843. | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. | CareFusion 213, LLC / 3,032,000 applicators | Class II | Terminated |
| D-224-2013 | 03-04-2013 | SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS 66211. | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. | CareFusion 213, LLC / 698,000 applicators | Class II | Terminated |
| D-228-2013 | 03-04-2013 | Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, CareFusion, Leawood, KS 66211. | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. | CareFusion 213, LLC / 46,500 kits | Class II | Terminated |
| D-596-2013 | 03-02-2013 | Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00 | Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be legible. | Physicians Total Care, Inc. / 76 Tubes | Class III | Terminated |
| D-398-2014 | 02-27-2013 | FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots | Mutual Pharmaceutical Company, Inc. / | Class III | Terminated |
| D-400-2014 | 02-27-2013 | Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots | Mutual Pharmaceutical Company, Inc. / | Class III | Terminated |
| D-623-2013 | 02-27-2013 | 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11 Package NDCs: 0338-0553-11; 0338-0553-18 | Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL. | Baxter Healthcare Corp. / 317,280 bags | Class II | Terminated |
| D-399-2014 | 02-27-2013 | Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07 | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots | Mutual Pharmaceutical Company, Inc. / | Class III | Terminated |
| D-269-2013 | 02-26-2013 | Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10 | Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets.. | Mylan Pharmaceuticals Inc. / 2,405 bottles | Class III | Terminated |
| D-247-2013 | 02-26-2013 | Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960. Package NDCs: 0093-4136-64; 0093-4136-73; 0093-4137-64; 0093-4137-73 | Defective Container: This recall is being carried out due to the potential for improperly sealed bottles. | Teva Pharmaceuticals USA, Inc. / 62,187 bottles | Class II | Terminated |
| D-886-2013 | 02-26-2013 | Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887 | Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment. | Sanofi-Synthelabo / 998 Bottles | Class II | Terminated |
| D-315-2013 | 02-26-2013 | QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 0409-6629-02 Package NDCs: 0409-6629-12; 0409-6629-02 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. / 139,200 vials | Class II | Terminated |
| D-316-2013 | 02-26-2013 | Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73 Package NDCs: 0409-7299-83; 0409-7299-73 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. / 266,900 vials | Class II | Terminated |
| D-313-2013 | 02-26-2013 | Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 Package NDCs: 0409-3213-11; 0409-3213-12 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. / 114,000 vials | Class II | Terminated |
| D-314-2013 | 02-26-2013 | Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04 Package NDCs: 0409-6102-19; 0409-6102-02; 0409-6102-18; 0409-6102-04; 0409-6102-20; 0409-6102-10 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. / 259,050 vials | Class II | Terminated |
| D-223-2013 | 02-25-2013 | Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA. Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25; 0409-1511-97; 0409-1511-98; 0409-0501-97; 0409-0501-98; 0409-0010-97; 0409-0010-98 | Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection. | Hospira Inc. / 68,020 vials | Class II | Terminated |
| D-346-2014 | 02-22-2013 | Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6. Package NDCs: 68180-280-01; 68180-281-01; 68180-281-02; 68180-281-11 | Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity. | Lupin Pharmaceuticals Inc. / 4896 bottles | Class III | Terminated |
| D-579-2013 | 02-22-2013 | Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN | cGMP Deviation | Petnet Solution Inc / 28 doses | Class II | Terminated |
| D-575-2013 | 02-19-2013 | Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code: 300673999428. | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. | Novartis Consumer Health / 219,600 tubes | Class III | Terminated |
| D-577-2013 | 02-19-2013 | Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ. | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. | Novartis Consumer Health / a) 1,043,926 (20-gm) tubes and b) 3,385,481 (100-gm) tubes | Class III | Terminated |
| D-574-2013 | 02-19-2013 | Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis, MN. | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.. | Novartis Consumer Health / 99,660 tubes | Class III | Terminated |
| D-576-2013 | 02-19-2013 | Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43 | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. | Novartis Consumer Health / 41,400 Boxes | Class III | Terminated |
| D-573-2013 | 02-19-2013 | Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged with UPC code: 300673998308 and NDC code: 0067-3998-30; (d) 30 gm (1 oz), packaged with UPC code: 300673998339 and NDC code: 0067-3998-33. | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. | Novartis Consumer Health / 818,064 (12-gm) tubes and 836,376 (30-gm) tubes | Class III | Terminated |
| D-243-2013 | 02-18-2013 | 0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045 | Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal. | Hospira Inc. / 624,240 units | Class II | Terminated |
| D-216-2013 | 02-18-2013 | PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716 | Subpotent; 12 month time point for the active ingredient Phenylephrine HCl. | L. Perrigo Co. / 60,048 Blister packs | Class III | Terminated |
| D-304-2013 | 02-15-2013 | Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880. | Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged. | Warner Chilcott Company LLC / 17,136 bottles | Class III | Terminated |
| D-305-2013 | 02-15-2013 | 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 by Warner Cholcott (US), LLC, Rockaway, NJ 07866 | Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged. | Warner Chilcott Company LLC / 6,408 bottles | Class III | Terminated |
| D-303-2013 | 02-15-2013 | 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 by Warner Cholcott (US), LLC, Rockaway, NJ 07866 | Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged. | Warner Chilcott Company LLC / 27,509 bottles | Class III | Terminated |
| D-206-2013 | 02-15-2013 | METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24) | Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal. | Hospira Inc. / 567,624 bags | Class II | Terminated |
| D-239-2013 | 02-15-2013 | 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., Bridgewater, NJ 08807 | Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point. | Dr Reddys Laboratories Tennessee LLC / 4236 Bottles | Class II | Terminated |
| D-205-2013 | 02-13-2013 | 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 Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton; NDC 52544-981-28 | Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) . | Watson Laboratories Inc / 136,720 cartons | Class II | Terminated |
| D-182-2013 | 02-13-2013 | 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 Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430. | Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA). | Glenmark Generics Inc., USA / 591,972 bottles | Class III | Terminated |
| D-190-2013 | 02-13-2013 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11. Package NDCs: 0228-3062-11; 0228-3059-11; 0228-3063-11; 0228-3060-11; 0228-3064-11; 0228-3061-11 | Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met. | Actavis Elizabeth LLC / 9,264 Bottles | Class III | Terminated |
| D-176-2013 | 02-12-2013 | 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08 | Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container. | Hospira Inc. / 56,854 Units | Class II | Terminated |
| D-600-2013 | 02-12-2013 | 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 | Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug. | OLAAX International / 600 boxes | Class I | Terminated |
| D-296-2013 | 02-11-2013 | 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, MD 21801 NDC 59746-284-90 | cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices. | Jubilant Cadista Pharmaceuticals Inc. / 12770 bottles | Class II | Terminated |
| D-203-2013 | 02-08-2013 | 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 | Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone . | Watson Laboratories Inc / 9,824 bottles | Class II | Terminated |
| D-204-2013 | 02-08-2013 | 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 | Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone . | Watson Laboratories Inc / 20,587 bottles | Class II | Terminated |
| D-237-2013 | 02-07-2013 | 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 | Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity. | Teva Pharmaceuticals USA, Inc. / 3 boxes | Class II | Terminated |
| D-220-2013 | 02-06-2013 | 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 Package NDCs: 0143-9927-01; 0143-9927-05; 0143-9927-30; 0143-9928-01; 0143-9928-05; 0143-9928-30; 0143-9929-01; 0143-9929-50 | Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet. | West-ward Pharmaceutical Corp. / 7,136 units | Class II | Terminated |
| D-892-2013 | 02-04-2013 | 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 Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01 | Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds. | American Health Packaging / 389 cartons | Class III | Terminated |
| D-307-2013 | 02-04-2013 | 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, 0.005 mL), 120 mL bottle, Manufactured by: P.A. Benjamin Manufacturing Co. Ltd., 97 East Street, Kingston, JAMAICA; UPC 0 83276 34324 8. | CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices. | Carib Import & Export, Inc. / 480 bottles | Class II | Terminated |
| D-200-2013 | 02-01-2013 | 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, NDC 63323-311-10 | Labeling: Missing label | Fresenius Kabi USA LLC (FK USA) / 155,900 vials domestically | Class III | Terminated |
| D-240-2013 | 02-01-2013 | 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 Manufactured in Israel. | Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A | Ferring Pharmaceuticals Inc / 126 injectors | Class III | Terminated |
| D-264-2013 | 01-31-2013 | 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 Lupin Limited Mumbai 400 058 India, NDC 68180-202-03. | Discoloration; Product may not meet specifications for color description once reconstituted. | Lupin Pharmaceuticals Inc. / 64,368 bottles | Class III | Terminated |
| D-324-2013 | 01-31-2013 | 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. | Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection). | Gilead Sciences, Inc. / 3,181 vials | Class I | Terminated |
| D-312-2013 | 01-31-2013 | 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, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained. | Noven Pharmaceuticals, Inc. / 335,910 patches | Class II | Terminated |
| D-147-2013 | 01-30-2013 | 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. Package NDCs: 0378-8015-93; 0378-8030-93; 0378-8030-77; 0378-8030-05 | Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets. | Mylan Pharmaceuticals Inc. / 1,894 bottles | Class II | Terminated |
| D-538-2013 | 01-30-2013 | TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 98,202 16 ounce bottles. | Class II | Terminated |
| D-526-2013 | 01-30-2013 | 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 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 57,936 bottles - 20 mL and 7,476 bottles -16 ounce | Class II | Terminated |
| D-504-2013 | 01-30-2013 | AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 348 - 16 ounce bottles. | Class II | Terminated |
| D-513-2013 | 01-30-2013 | AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 886 bottles - 100-count tablets | Class II | Terminated |
| D-541-2013 | 01-30-2013 | Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 39,403 - 30 mL bottles | Class II | Terminated |
| D-506-2013 | 01-30-2013 | 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 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 348 - 16 ounce bottles | Class II | Terminated |
| D-529-2013 | 01-30-2013 | Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 330158 Bulk tablets. | Class II | Terminated |
| D-533-2013 | 01-30-2013 | CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 6551 30 mL bottles | Class II | Terminated |
| D-519-2013 | 01-30-2013 | BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 22,721 - 16 ounce bottles | Class II | Terminated |
| D-544-2013 | 01-30-2013 | Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 2388 - 16 ounce bottles. | Class II | Terminated |
| D-524-2013 | 01-30-2013 | BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 10,036 bottles - 100-count tablets | Class II | Terminated |
| D-542-2013 | 01-30-2013 | Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 40,149 - 30 mL bottles. | Class II | Terminated |
| D-521-2013 | 01-30-2013 | Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 216,838 bottles - 30 mL | Class II | Terminated |
| D-515-2013 | 01-30-2013 | ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 242,470 | Class II | Terminated |
| D-528-2013 | 01-30-2013 | Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / N/A | Class II | Terminated |
| D-522-2013 | 01-30-2013 | Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 2706 bottles of 100 count tablets | Class II | Terminated |
| D-510-2013 | 01-30-2013 | 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 66870-0230-16. | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 348 - 16 ounce bottles | Class II | Terminated |
| D-511-2013 | 01-30-2013 | 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 66870-0229-16 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 348 - 16 ounce bottles | Class II | Terminated |
| D-518-2013 | 01-30-2013 | Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 8296 bottles - 100-count and 153,028 Bulk tablets | Class II | Terminated |
| D-517-2013 | 01-30-2013 | Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 31,739 bottles 100-count; 842,617 Bulk tablet bottles | Class II | Terminated |
| D-531-2013 | 01-30-2013 | 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 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 978,092 Bulk Tablets | Class II | Terminated |
| D-536-2013 | 01-30-2013 | Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 4,884 - 16 ounce bottles | Class II | Terminated |
| D-539-2013 | 01-30-2013 | TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 13,031 30 mL bottles. | Class II | Terminated |
| D-543-2013 | 01-30-2013 | Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 12,988 - 30 mL bottles. | Class II | Terminated |
| D-507-2013 | 01-30-2013 | 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 66870-0224-16 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 348 - 16 ounce bottles | Class II | Terminated |
| D-509-2013 | 01-30-2013 | 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. | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 355 - 16 ounce bottles | Class II | Terminated |
| D-525-2013 | 01-30-2013 | BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 16,836 bottles - 100-count. | Class II | Terminated |
| D-537-2013 | 01-30-2013 | TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 2532 - 16 ounce bottles. | Class II | Terminated |
| D-530-2013 | 01-30-2013 | Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 977,719 Bulk Tablets | Class II | Terminated |
| D-523-2013 | 01-30-2013 | Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 1623 bottles of 100-count tablets. | Class II | Terminated |
| D-546-2013 | 01-30-2013 | ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 4811 - 16 ounce bottles. | Class II | Terminated |
| D-527-2013 | 01-30-2013 | 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 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce. | Class II | Terminated |
| D-512-2013 | 01-30-2013 | AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 1772 bottles per 100 count each | Class II | Terminated |
| D-545-2013 | 01-30-2013 | ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 39,801 - 30 mL bottles. | Class II | Terminated |
| D-508-2013 | 01-30-2013 | AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16. | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 348 - 16 ounce bottles. | Class II | Terminated |
| D-540-2013 | 01-30-2013 | Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 12,198 - 16 ounce bottles. | Class II | Terminated |
| D-514-2013 | 01-30-2013 | 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 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 2957 bottles 100-count tablets | Class II | Terminated |
| D-505-2013 | 01-30-2013 | 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 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 352 - 16 ounce bottles | Class II | Terminated |
| D-532-2013 | 01-30-2013 | TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 386 - 1000-count bottles | Class II | Terminated |
| D-516-2013 | 01-30-2013 | NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 4824 bottles - 100-count | Class II | Terminated |
| D-520-2013 | 01-30-2013 | Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 26,536 bottles - 30 mL | Class II | Terminated |
