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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
| 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-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-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-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-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-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-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-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-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-535-2013 | 01-30-2013 | Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 12,120 - 16 ounce bottles | Class II | Terminated |
| D-534-2013 | 01-30-2013 | CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 26,315 - 30 mL bottles. | Class II | Terminated |
| D-503-2013 | 01-30-2013 | AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04 | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. / 1398 - 4 ounce bottles | 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-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-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-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-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-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-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-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-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-144-2013 | 01-28-2013 | Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp., Eatontown, NJ 07724, Packaged and Distributed by: Stat Rx USA, NDC 42549-521-90. | Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16. | Stat Rx USA / 3 bottles | Class III | Terminated |
| D-262-2013 | 01-25-2013 | Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA; NDC 0409-7929-09. | Non-Sterility: Confirmed customer complaint of product contaminated with mold. | Hospira Inc. / 143,136 flexible containers | Class I | Terminated |
| D-167-2013 | 01-23-2013 | Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz),Dist. by Procter & Gamble, Cincinnati, OH 45202 NDC 37000-452-02 | Cross Contamination with Other Products: Product was mixed with another type of mouth wash. | Procter & Gamble Hair Care Llc / 71,040 bottles | Class III | Terminated |
| D-193-2013 | 01-23-2013 | Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India - 382 210; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. | Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle. | Teva Pharmaceuticals USA, Inc. / 3,913 bottles | Class II | Terminated |
| D-602-2013 | 01-23-2013 | Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE | Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength. | Mission Pharmacal Co / 8,437 bottles | Class III | Terminated |
| D-191-2013 | 01-22-2013 | Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx3 Compounding Pharmacy, 12230 Ironbridge Rd., Suite C, Chester, VA 23831. | CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures. | RX South LLC DBA RX3 Pharmacy / 126 vials | Class II | Terminated |
| D-915-2013 | 01-22-2013 | IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7. | Crystallization: Active pharmaceutical ingredient is precipitating in product solution. | Fresenius Kabi USA LLC (FK USA) / 23,672 vials | Class II | Terminated |
| D-152-2013 | 01-22-2013 | Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ | Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3. | Sandoz Incorporated / 17,188 cartons containing 3 cards each. | Class III | Terminated |
| D-187-2013 | 01-18-2013 | Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-5), Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA. | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. | Aaron Industries Inc / 5,676 bottles (473 cases) | Class III | Terminated |
| D-186-2013 | 01-18-2013 | Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011 | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. | Aaron Industries Inc / 35,652 bottles (2,971 cases) | Class III | Terminated |
| D-185-2013 | 01-18-2013 | Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08 | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. | Aaron Industries Inc / 6,108 bottles (509 cases) | Class III | Terminated |
| D-188-2013 | 01-18-2013 | Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712. | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. | Aaron Industries Inc / 43,464 bottles (3,622 cases) | Class III | Terminated |
| D-197-2013 | 01-17-2013 | Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic, Sold under the following brands: a) Good Neighbor Pharmacy, NDC 24385-593-46; b) Quality Choice, NDC 63868-0488-02; c) Select Brand NDC 15127-885-59; d) Premier Value; e) CVS Pharmacy; f) Rite Aid Pharmacy; g) Top Care; h) HEB; and i) Humco. | Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli. | Humco Holding Group, Inc / 1,269,846 bottles | Class II | Terminated |
| D-143-2013 | 01-16-2013 | Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30. | Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point. | Actelion Pharmaceuticals U.S., Inc. / 3 Cartons | Class III | Terminated |
| D-137-2013 | 01-16-2013 | Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3. | Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness. | Mylan Pharmaceuticals Inc. / 11,580 bottles | Class II | Terminated |
| D-199-2013 | 01-11-2013 | PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04 Package NDCs: 0186-1988-04; 0186-1989-04; 0186-1990-04 | Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. | AstraZeneca LP / 64675 cartons | Class III | Terminated |
| D-198-2013 | 01-11-2013 | PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04 Package NDCs: 0186-1988-04; 0186-1989-04; 0186-1990-04 | Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. | AstraZeneca LP / 28,476 cartons | Class III | Terminated |
| D-169-2013 | 01-10-2013 | Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- 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; possible loose crimp applied to fliptop vial | Hospira, Inc. / 63,900 vials | Class II | Terminated |
| D-183-2013 | 01-08-2013 | 0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23, | Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal. | Hospira Inc. / 325,056 bags | Class II | Terminated |
| D-170-2013 | 01-07-2013 | Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 | Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets. | West-ward Pharmaceutical Corp. / 6,511 bottles | Class II | Terminated |
| D-164-2013 | 01-07-2013 | Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01. | Subpotent Drug | West-ward Pharmaceutical Corp. / 1,185 Bottles | Class III | Terminated |
| D-175-2013 | 01-04-2013 | buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217 | Failed Dissolution Specifications; 8-hours for the 18-month stability testing point. | Actavis Pharmaceuticals / 14,856 bottles | Class III | Terminated |
| D-837-2013 | 01-04-2013 | Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico. | Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol. | Reumofan Plus USA / 586 bottles | Class I | Terminated |
| D-809-2013 | 01-03-2013 | Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenue, St. Louis, MO 63108 USA. Package NDCs: 49771-002-01; 49771-002-03 | Non-Sterility: one or more components of the kit have been found to be contaminated with yeast. | Mobius Therapeutics LLC / 83 boxes | Class I | Terminated |
| D-140-2013 | 12-28-2012 | HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03 Package NDCs: 76402-403-06; 76402-403-03; 76402-403-02; 76402-403-82 | Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria. | Hillyard GMP / 2,139 bottles | Class II | Terminated |
| D-601-2013 | 12-28-2012 | Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013 | Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness) | Advance Pharmaceutical Inc / 19,944 bottles | Class I | Terminated |
| D-163-2013 | 12-27-2012 | Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28; b) 385 g bottle, NDC 10631-099-38; Rx only, Ranbaxy, Jacksonville, FL 32257 USA. | Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product. | Ranbaxy Inc. / 6,535 tubes and bottles | Class III | Terminated |
| D-162-2013 | 12-27-2012 | Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14. | Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product. | Ranbaxy Inc. / 4,016 bottles | Class III | Terminated |
| D-323-2013 | 12-22-2012 | Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9. | Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an unapproved new drug. | D& S Herbals, LLC / 40,480 blister packs | Class I | Terminated |
| D-161-2013 | 12-21-2012 | 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Proudly Distributed By: Valu Merchandisers, Co., Kansas City, MO 64111, UPC 0 70038 61226 1; b) Nasal Spray Sinus, Distributed by Discount Drug Mart, Medina, Ohio 44258, UPC 0 9335112623 9; c) sinus relief nasal spray, Distributed By DUANE reade, 440 Ninth Avenue, NY, NY 10001, UPC 6 39194 04551 3; d) 12 Hour Nasal Relief Sinus Nasal Spray, Distributed by: Lee Pharmaceuticals, South El Monte, CA 91733, UPC 0 23558 69230 5; e) Sinus Nasal Spray, Premier Value, Distributed By: Chain Drug Consortium, LLC, 2300 NW Corporate Blvd., Suite 115, Boca Raton, FL 33431, UPC 8 40986 01517 5, NDC 68016-0307-03; f) Nasal Relief Sinus Squeeze Spray, Distributed By Quality Choice, Novi, Michigan 48376-0995, UPC 6 35515 99012 8, NDC 63868-0062-30; g) sinus relief nasal spray, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 14576 3; h) Sinus Nasal Spray, Distributed by: Select Brand Distributors, Pine Bluff, AR 71603, UPC 015127 02305 4, NDC 15127-889-30. | Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing. | Lee Pharmaceuticals, Inc / 32,460 bottles | Class II | Terminated |
| D-141-12013 | 12-21-2012 | Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738 | Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles | Warner Chilcott Company LLC / 5439 bottles | Class III | Terminated |
| D-142-2013 | 12-21-2012 | Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738 | Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles | Warner Chilcott Company LLC / 3155 bottles | Class III | Terminated |
| D-165-2013 | 12-19-2012 | SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA. | Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug. | P & J Trading Co / unknown | Class I | Terminated |
| D-136-2013 | 12-18-2012 | Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg, 12 fl oz (355 mL) bottles, Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203, UPC 8 53030 00209 0, NDC 27854.101.01. | Defective Container: Product lacks tamper evident breakaway band on cap. | Belmora LLC / 17,996 bottles | Class III | Terminated |
| D-155-2013 | 12-18-2012 | Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0. | Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia. | Matrixx Initiatives Inc / 46,752 bottles | Class I | Terminated |
| D-145-2013 | 12-18-2012 | Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90. | Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%). | Watson Pharmaceuticals / 3,040 bottles | Class II | Terminated |
| D-168-2013 | 12-17-2012 | EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA | Subpotent; bupivacaine | Pacira Pharmaceuticals, Inc. / 324 vials | Class II | Terminated |
| D-125-2013 | 12-17-2012 | Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040. | Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions | L. Perrigo Co. / 86,616 Tablets | Class II | Terminated |
| D-336-2013 | 12-17-2012 | Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister packs, Distributed By: Mojo Health, Pompano Beach, FL I count blister UPC - 718122119738; 5 count blister UPC - 705105836430; | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs | Performance Plus Marketing, Inc. / 219,000 capsules. | Class I | Terminated |
