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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1245-2014 | 02-20-2014 | Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03. Package NDCs: 0135-0508-02; 0135-0508-03; 0135-0508-04; 0135-0509-02; 0135-0509-03; 0135-0509-04; 0125-0508-03 | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 834,072 81 ct Vials, 414,500 20 ct Vials, 9456 135 ct Vials | Class III | Terminated |
| D-1239-2014 | 02-20-2014 | Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01. | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 304,332 72 Ct Vials, 85,080 81 Ct Vials 22,992 108 Ct Vials | Class III | Terminated |
| D-1243-2014 | 02-20-2014 | Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03. | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 146,424 81 Ct. Vials, 105,091 189 Ct Vials | Class III | Terminated |
| D-1240-2014 | 02-20-2014 | Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07. Package NDCs: 0135-0510-01; 0135-0510-06; 0135-0510-07; 0135-0511-01; 0135-0511-06; 0135-0511-07; 0135-0515-03; 30142-862-01; 0363-0209-01; 0363-0209-07 | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 603,696 72 Ct Vials, 191,040 108 Ct Vials | Class III | Terminated |
| D-1242-2014 | 02-20-2014 | Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03. | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 147,684 81 Ct Vials, 130564 189 Ct Vials | Class III | Terminated |
| D-1244-2014 | 02-20-2014 | Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2. | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 12,162 Pallets | Class III | Terminated |
| D-1246-2014 | 02-20-2014 | Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02. Package NDCs: 0135-0508-02; 0135-0508-03; 0135-0508-04; 0135-0509-02; 0135-0509-03; 0135-0509-04 | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 189,900 20 ct Vials, 145,068 81 ct Vials | Class III | Terminated |
| D-1247-2014 | 02-20-2014 | Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2. | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 150 cases | Class III | Terminated |
| D-1241-2014 | 02-20-2014 | Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07. Package NDCs: 0135-0510-01; 0135-0510-06; 0135-0510-07; 0135-0511-01; 0135-0511-06; 0135-0511-07; 0135-0514-03; 30142-861-01; 0363-0208-07 | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 488,628 72 Ct Vial, 255,594 108 Ct Vial | Class III | Terminated |
| D-1238-2014 | 02-20-2014 | Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0446-01. | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 109,848 72 Ct Vials, 61,332 81 Ct Vials, 16,218 108 Ct Vials | Class III | Terminated |
| D-1090-2014 | 02-19-2014 | Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only. Manufactured for: Bristol-Myers Squibb & Gilead Sciences, LLC, Foster City, CA 94404. Made in Ireland. NDC 15584-0101-1. Manufactured for: Bristol-Myers-Squibb & Gilead Sciences, LLC, Foster City, CA 94404 Made in Ireland | Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug. | Gilead Sciences, Inc. / 39,223 bottles | Class III | Terminated |
| D-1279-2014 | 02-14-2014 | Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5. Package NDCs: 68645-131-54; 68645-130-54 | Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor. | Legacy Pharmaceutical Packaging / 667,068 bottles | Class II | Terminated |
| D-1225-2014 | 02-14-2014 | etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer Labs; Division of Pfizer Inc., New York, NY 10017. | Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials. | Agila Specialties Private Ltd. / 7919 cartons | Class II | Terminated |
| D-1326-2014 | 02-14-2014 | Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02 | Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution | Ben Venue Laboratories Inc / 5,131 vials | Class I | Terminated |
| D-0674-2016 | 02-14-2014 | CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by Medisca Inc. Plattsburgh, NY 12901, USA, NDC #s: 38779-1186-4 (25 g), 38779-1186-5 (100 g), 38779-1186-8 (500 g), 38779-1186-9 (1 kg). | Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead. | Medisca Inc / 25 g: 15 bottles, 100 g: 153 bottles; 500 g: 18 bottles, 1 kg: 24 bottles | Class I | Terminated |
| D-1422-2014 | 02-13-2014 | BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas 77478, NDC 75901-7210-53. | Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial. | Healix Infusion Therapy, Inc. / 10 bags | Class II | Terminated |
| D-1171-2014 | 02-13-2014 | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/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 68968-5554-3. 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. / 187,860 patches | Class II | Terminated |
| D-1172-2014 | 02-13-2014 | Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch 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 68968-5555-3. 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. / 117,600 patches | Class II | Terminated |
| D-1281-2014 | 02-12-2014 | Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5. Package NDCs: 50111-647-01; 50111-647-02; 50111-647-03; 50111-648-01; 50111-648-02; 50111-648-03; 50111-648-44 | Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. | Teva Pharmaceuticals USA / 72,356 bottles | Class II | Terminated |
| D-1280-2014 | 02-12-2014 | Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. Package NDCs: 50111-647-01; 50111-647-02; 50111-647-03; 50111-648-01; 50111-648-02; 50111-648-03; 50111-648-44 | Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. | Teva Pharmaceuticals USA / 257904 bottles | Class II | Terminated |
| D-1185-2014 | 02-11-2014 | Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13 Package NDCs: 49702-255-37; 49702-226-13; 49702-227-13; 49702-228-13 | Cross Contamination with Other Products: Product contains Promacta (eltrombopag). | Viiv Healthcare Company / 1,056 bottles | Class III | Terminated |
| D-1096-2014 | 02-11-2014 | 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09 | Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection. | Hospira Inc. / 603,768 bags | Class II | Terminated |
| D-1190-2014 | 02-11-2014 | QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324. | Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point | Teva Pharmaceuticals USA / 257,832 cylinders | Class III | Terminated |
| D-1276-2014 | 02-11-2014 | Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11 Package NDCs: 0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0427-52; 0941-0427-53; 0941-0429-52; 0941-0429-53; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0484-01; 0941-0487-01; 0941-0490-01 | Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch. | Baxter Healthcare Corp. / 27,169 containers | Class I | Terminated |
| D-1147-2014 | 02-10-2014 | Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02 Package NDCs: 0409-1159-18; 0409-1159-01; 0409-1159-19; 0409-1159-02; 0409-1160-18; 0409-1160-01; 0409-1162-18; 0409-1162-01; 0409-1162-19; 0409-1162-02; 0409-1163-18; 0409-1163-01; 0409-1165-18; 0409-1165-01; 0409-1165-19; 0409-1165-02; 0409-9043-11; 0409-9043-01; 0409-9046-11; 0409-9046-01; 0409-9045-11; 0409-9045-01; 0409-9045-16; 0409-9045-17; 0409-9042-11; 0409-9042-01; 0409-9042-16; 0409-9042-17 | Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial. | Hospira Inc. / 115,500 Vials | Class II | Terminated |
| D-1157-2014 | 02-10-2014 | Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75 Package NDCs: 76128-155-75 | Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014. | Pinnacle Biologics Inc / 261 vials | Class III | Terminated |
| D-1153-2014 | 02-10-2014 | Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50 Package NDCs: 0228-2027-10; 0228-2027-50; 0228-2027-96; 0228-2029-10; 0228-2029-50; 0228-2029-96; 0228-2031-10; 0228-2031-50; 0228-2031-96; 0228-2039-10 | Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg. | Actavis Elizabeth LLC / 9447 Bottles | Class II | Terminated |
| D-1088-2014 | 02-07-2014 | Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77. | Subpotent Drug: Drug potency was compromised during shipment. | Actavis / 38,227 Clamshells | Class III | Terminated |
| D-1256-2014 | 02-07-2014 | Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only. Labeled A) CVS Allergy Relief - D, Pseudoephedrine, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, 5-count box Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02805 UPC 050428049631 B) Discount Drug Mart Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Loratadine, USP 10 mg/Antihistamine Pseudephrine Sulfate, USP 240 mg/Nasal Decongestant Extended Release Tablets, 15-count box Distributed by Drug Mart-Food Fair Medina, Ohio 44256 UPC 093351116285 C) Kroger Non-Drowsy Allergy and Congestion Loratadine and Pseudoephedrine Extended Release Tablets Pseudoephedrine Sulfate, USP 240 mg Nasal Decongestant Loratadine, USP 10 mg, Antihistamine 10- count box, Distributed by The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-0724-69. D) Sunmark Allergy & Congestion Lorata*dine D Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, Indoor & Outdoor Allergies, Non-Drowsy 10- count box, Distributed by Mckesson One Post Street, San Francisco, CA 94104 NDC 49348-543-01 E) Good Neighbor Pharmacy Non-Drowsy Allergy and Congestion Relief pseudoephedrine sulfate, USP 240 mg/nasal decongestant loratadine, USP 10 mg/antihistamine Indoor & Outdoor Allergies Extended-Release Tablets, 10- count box, Distributed by Amerisource Bergen 1300 Morris Drive, Chesterbrook, PA 19087 NDC46122-0167-52 F) H-E-B Allergy Relief - D Non-Drowsy- 24 Hour Formula Loratadine, USP 10mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/Nasal Decogestant Indoor & Outdoor Allegies, Allergy & Congestion Extended-Release Tablets 10-count box, Distributed by H-E-B San Antonio, TX 78204 NDC 37808-0724-69 G) Rite Aid Pharmacy allergy relief & nasal decongestant loratadine USP, 10 mg, pseudoephedribe sulfate USP, 240 mg, antihistamine & nasal degestant, extended release tablets, 10- count box, Distributed by: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 UPC 0118223315555 Package NDCs: 49348-543-01; 49348-543-57; 0504280496; 0933511162; 30142-0724-69; 46122-0167-52; 37808-0724-69; 0118223315 | Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg. | Ohm Laboratories, Inc. / 29,790 blister packs | Class II | Terminated |
| D-1097-2014 | 02-04-2014 | Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3. | Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out. | Aaron Industries Inc / 43,921 bottles | Class III | Terminated |
| D-1091-2014 | 02-04-2014 | Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2. | Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. | Actavis Elizabeth LLC / 5,148 bottles | Class II | Terminated |
| D-1177-2014 | 01-31-2014 | ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04 Package NDCs: 68791-102-04; 68791-102-01 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 7,292 bottles | Class III | Terminated |
| D-1176-2014 | 01-31-2014 | ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04 Package NDCs: 68791-101-04; 68791-101-01 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 8,734 bottles | Class III | Terminated |
| D-1178-2014 | 01-31-2014 | ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20 Package NDCs: 68791-103-20 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 13,379 bottles | Class III | Terminated |
| D-1181-2014 | 01-31-2014 | SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 13,591 bottles | Class III | Terminated |
| D-1179-2014 | 01-31-2014 | SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 4,142 bottles | Class III | Terminated |
| D-1173-2014 | 01-31-2014 | DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 4,080 bottles | Class III | Terminated |
| D-1174-2014 | 01-31-2014 | Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 14,226 bottles | Class III | Terminated |
| D-1188-2014 | 01-31-2014 | HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01 | Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. | American Health Packaging / 14,665 blister packs | Class II | Terminated |
| D-1189-2014 | 01-31-2014 | HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01 | Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. | American Health Packaging / 8,570 blister packs | Class II | Terminated |
| D-1175-2014 | 01-31-2014 | Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 8,734 bottles | Class III | Terminated |
| D-1180-2014 | 01-31-2014 | SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 7,676 bottles | Class III | Terminated |
| D-1081-2014 | 01-29-2014 | Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. NDC 62756-184-88, Rx only, 100 Tablets; Pharmacist: Dispense the Medication Guide provided separately to each patient. Each film-coated tablet contains 300 mg oxcarbazepine, USP, Usual Dosage: See package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted.... Distributed by Caraco Pharmaceuticals Detroit, MI.... Package NDCs: 62756-183-83; 62756-183-88; 62756-183-08; 62756-183-13; 62756-183-18; 62756-184-83; 62756-184-88; 62756-184-08; 62756-184-13; 62756-184-18; 62756-185-83; 62756-185-88; 62756-185-08; 62756-185-13; 62756-185-18 | Failed Tablet Specifications: Broken Tablets Present. | Caraco Pharmaceutical Laboratories Ltd. / 7005 bottles | Class II | Terminated |
| D-1356-2014 | 01-29-2014 | GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1 Package NDCs: 59762-5015-1; 59762-5016-1; 59762-5017-1; 59762-5018-1; 59762-5029-1; 59762-5030-1 | Defective Container: Tamper evident ring failures discovered on some bottles. | Pfizer Inc. / 4,155 bottles | Class II | Terminated |
| D-1152-2014 | 01-29-2014 | Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8. Package NDCs: 0168-0003-15; 0168-0003-80; 0168-0004-15; 0168-0004-80; 0168-0004-16; 0168-0002-15 | Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%. | Fougera Pharmaceuticals Inc. / 493,192 tubes | Class III | Terminated |
| D-1089-2014 | 01-28-2014 | Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02 Package NDCs: 62756-142-01; 62756-142-02; 62756-143-01 | Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER | Caraco Pharmaceutical Laboratories, Ltd. / 2528 bottles | Class II | Terminated |
| D-1155-2014 | 01-28-2014 | Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20 | Failed Impurity/degradation Specification | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 3,252 cartons | Class III | Terminated |
| D-1164-2014 | 01-28-2014 | Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831*** | Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping | RX South LLC DBA RX3 Pharmacy / 250 syringes | Class II | Terminated |
| D-1186-2014 | 01-27-2014 | Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02. | Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station. | Lupin Pharmaceuticals Inc. / 4,038 bottles | Class III | Terminated |
| D-1187-2014 | 01-27-2014 | Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-03. | Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station. | Lupin Pharmaceuticals Inc. / 5,172 bottles | Class III | Terminated |
| D-1095-2014 | 01-24-2014 | Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02. Package NDCs: 0555-0323-02; 0555-0323-04; 0555-0302-02; 0555-0302-04; 0555-0324-02 | CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. | Teva Pharmaceuticals USA / 35746 capsules | Class II | Terminated |
| D-1093-2014 | 01-24-2014 | Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02 Package NDCs: 0555-0323-02; 0555-0323-04; 0555-0302-02; 0555-0302-04; 0555-0324-02 | CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. | Teva Pharmaceuticals USA / 2494 capsules | Class II | Terminated |
| D-1094-2014 | 01-24-2014 | Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02. Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment. | Teva Pharmaceuticals USA / 9796 tablets | Class II | Terminated |
| D-1376-2014 | 01-24-2014 | SlimEasy Herbs Capsule, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine | MyNicNaxs, Inc. / 2 boxes | Class I | Terminated |
| D-1092-2014 | 01-24-2014 | Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02. | CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation. | Teva Pharmaceuticals USA / 10405 tablets | Class II | Terminated |
| D-1374-2014 | 01-24-2014 | Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine | MyNicNaxs, Inc. / unknown | Class I | Terminated |
| D-1377-2014 | 01-24-2014 | Meizi Evolution Soft Gel Capsules, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine | MyNicNaxs, Inc. / 5 bottles | Class I | Terminated |
| D-1373-2014 | 01-24-2014 | Fruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein . | MyNicNaxs, Inc. / 2 boxes | Class I | Terminated |
| D-1379-2014 | 01-24-2014 | Magic Slim capsules, supplied in 60 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine | MyNicNaxs, Inc. / unknown | Class I | Terminated |
| D-1378-2014 | 01-24-2014 | Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product from Globe All Wellness, LLC Hollywood, FL 33020, distributed by MyNicKnaxs, LLC Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine | MyNicNaxs, Inc. / unknown | Class I | Terminated |
| D-1372-2014 | 01-24-2014 | JIANFEIJINDAN Activity Girl Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine | MyNicNaxs, Inc. / unknown | Class I | Terminated |
| D-1380-2014 | 01-24-2014 | Meizitang Strong Version Botanical Slimming, Soft Gel Capsules, 650 mg, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine | MyNicNaxs, Inc. / unknown | Class I | Terminated |
| D-1375-2014 | 01-24-2014 | Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd) 400 mg, supplied in 40 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein | MyNicNaxs, Inc. / unknown | Class I | Terminated |
| D-1371-2014 | 01-24-2014 | REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC., Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein. | MyNicNaxs, Inc. / 100 boxes | Class I | Terminated |
| D-1148-2014 | 01-22-2014 | Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11. Package NDCs: 63323-542-01; 63323-542-07; 63323-276-01; 63323-276-02; 63323-915-01; 63323-047-01; 63323-047-10; 63323-543-02; 63323-459-09; 63323-540-01; 63323-540-11; 63323-540-31; 63323-262-01 | Subpotent; 18 month time point | Fresenius Kabi USA, LLC / 161,650 vials | Class II | Terminated |
| D-1086-2014 | 01-16-2014 | Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90 Package NDCs: 63304-828-90; 63304-828-05; 63304-827-90; 63304-827-05; 63304-829-90; 63304-829-05; 63304-830-90; 63304-830-05 | Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg. | Ranbaxy Inc. / 64,626 bottles | Class II | Terminated |
| D-1041-2014 | 01-16-2014 | ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01074 9, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls. | The Mentholatum Co. / | Class II | Terminated |
| D-1039-2014 | 01-16-2014 | ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01096 1, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls. | The Mentholatum Co. / | Class II | Terminated |
| D-1040-2014 | 01-16-2014 | ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness Reliever Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01099 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls. | The Mentholatum Co. / | Class II | Terminated |
| D-1037-2014 | 01-16-2014 | ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls. | The Mentholatum Co. / 59, 376 units Total (32,184 units held in stock, quarantined) | Class II | Terminated |
| D-1038-2014 | 01-16-2014 | ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01086 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls. | The Mentholatum Co. / 94,080 units Total (432 units held in stock, quarantined) | Class II | Terminated |
| D-1053-2014 | 01-15-2014 | Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01. | Failed Tablet/Capsule Specifications; Product contains broken tablets. | Watson Laboratories Inc / 717 bottles | Class II | Terminated |
| D-1165-2014 | 01-14-2014 | Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001 | Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin. | Traxx International Corp / 30,800 Kg | Class II | Terminated |
| D-1084-2014 | 01-14-2014 | Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01 | Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification. | Mylan Pharmaceuticals Inc. / 138,970 bottles | Class II | Terminated |
| D-1312-2014 | 01-13-2014 | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 | Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. | Merck & Co Inc / 11,462 cartons | Class III | Terminated |
| D-1311-2014 | 01-13-2014 | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 | This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. | Merck & Co Inc / 36,493 cartons | Class III | Terminated |
| D-1310-2014 | 01-13-2014 | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC 66582-321-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 | This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. | Merck & Co Inc / 20,259 cartons | Class III | Terminated |
| D-1309-2014 | 01-13-2014 | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 | This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. | Merck & Co Inc / 11,175 cartons | Class III | Terminated |
| D-1327-2014 | 01-13-2014 | PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA | Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin | HUMAN SCIENCE FOUNDATION / 24,268 bottles | Class I | Terminated |
| D-1540-2014 | 01-10-2014 | DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02 Package NDCs: 0409-2344-01; 0409-2344-62; 0409-2344-02 | Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution. | Hospira Inc. / 123,900 vials | Class I | Terminated |
| D-1495-2014 | 01-10-2014 | Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit with SKU numbers of CR1005 and CR1007, respectively. | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / | Class II | Terminated |
| D-1491-2014 | 01-10-2014 | Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068. | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / | Class II | Terminated |
| D-1488-2014 | 01-10-2014 | Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020. | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / unknown | Class II | Terminated |
| D-1493-2014 | 01-10-2014 | Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005 | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / | Class II | Terminated |
| D-1487-2014 | 01-10-2014 | Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026 | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / unknown | Class II | Terminated |
| D-1490-2014 | 01-10-2014 | Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002. | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / unknown | Class II | Terminated |
| D-1494-2014 | 01-10-2014 | Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002 and in 50 ml containers in the Therametics Complexion Repair Acne Treatment System Kit with a SKU number of CR1005; and in 30 ml containers in the Therametics Complexion Repair Acne Travel Kit with a SKU number of CR1007. | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / | Class II | Terminated |
| D-1489-2014 | 01-10-2014 | Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008. | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / unknown | Class II | Terminated |
| D-1492-2014 | 01-10-2014 | Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019 | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / | Class II | Terminated |
| D-1035-2014 | 01-09-2014 | Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05 | Lack of Assurance of Sterility; potential leakage from administrative port. | Hospira Inc. / 15258 bags | Class II | Terminated |
| D-1335-2014 | 01-09-2014 | BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 500 1-ct blisters; 30 3-ct bottles, 4 12-ct bottles | Class I | Terminated |
| D-1339-2014 | 01-09-2014 | ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 57 boxes | Class I | Terminated |
| D-1338-2014 | 01-09-2014 | Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured For: BTQ Ski, Inc., Chicago, IL 60638 | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 59/1-ct blister pack, 97/12-ct bottles | Class I | Terminated |
| D-1337-2014 | 01-09-2014 | MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 49 blister packs | Class I | Terminated |
| D-1340-2014 | 01-09-2014 | XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 89 blister packs | Class I | Terminated |
| D-1036-2014 | 01-09-2014 | Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59. Package NDCs: 0409-7620-13; 0409-7620-03; 0409-7620-49; 0409-7620-59; 0409-1005-01; 0409-1005-20; 0409-2222-01; 0409-2222-12 | Lack of Assurance of Sterility; potential leakage from administrative port. | Hospira Inc. / 27780 bags | Class II | Terminated |
| D-1334-2014 | 01-09-2014 | XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 175 blister packs | Class I | Terminated |
| D-1336-2014 | 01-09-2014 | SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 2 blister packs | Class I | Terminated |
| D-1146-2014 | 01-03-2014 | a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe Road, Matthews, NC 28105 USA c) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 14 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 d) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 28 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 e) Equate Lansoprazole Delayed-Release Capsules USP, 15 mg Acid Reducer, 14 capsules per Bottle, and 28 capsules per bottle (Twin Pack)Distributed by Wal-mart Stores Inc. Bentonville, AR 72716 f) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 42 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 | Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules. | Dr. Reddy's Laboratories, Inc. / 58,656 Bottles | Class II | Terminated |
| D-745-2014 | 01-02-2014 | Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-84 Package NDCs: 0069-3150-84; 0069-3150-83 | Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant. | Pfizer Inc. / 101,681 Vials | Class III | Terminated |
