Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0001-2016 | 05-07-2012 | Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, FAIR, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250. | Subpotent Drug: Salicylic acid is subpotent. | Guthy-Renker LLC / 9,960 Compacts | Class III | Terminated |
| D-613-2013 | 05-04-2012 | 0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02 Package NDCs: 0409-7101-68; 0409-7101-66; 0409-7101-69; 0409-7101-67; 0409-7101-04; 0409-7101-02; 0409-7132-68; 0409-7132-66; 0409-7132-69; 0409-7132-67; 0409-7132-04; 0409-7132-02 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 136,584 units | Class II | Terminated |
| D-612-2013 | 05-04-2012 | 70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 14,706 units | Class II | Terminated |
| D-615-2013 | 05-04-2012 | 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 74,256 units | Class II | Terminated |
| D-611-2013 | 05-04-2012 | 0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 2,137,660 units | Class II | Terminated |
| D-618-2013 | 05-04-2012 | 1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 40,988 units | Class II | Terminated |
| D-617-2013 | 05-04-2012 | 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 98,084 units | Class II | Terminated |
| D-1383-2012 | 05-04-2012 | LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde | CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders. | Linde Gas LLC / 283 cylinders | Class II | Terminated |
| D-619-2013 | 05-04-2012 | 0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 2,933,936 units | Class II | Terminated |
| D-614-2013 | 05-04-2012 | 5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 267,288 units | Class II | Terminated |
| D-616-2013 | 05-04-2012 | 20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 216,396 units | Class II | Terminated |
| D-1397-2012 | 05-02-2012 | Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs | Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications. | Teva Pharmaceuticals USA, Inc. / 100,761 cartons | Class II | Terminated |
| D-1377-2012 | 05-01-2012 | Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL single dose vials per pack, Rx only, Manufactured for: Bedford Laboratories, Bedford, OH 44146; Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; NDC 55390-160-10; UPC 3 55390-160-10 1. | Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution. | Ben Venue Laboratories Inc / 6,515 packs | Class II | Terminated |
| D-1376-2012 | 05-01-2012 | Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for: Bedford Laboratories, Bedford, OH 44146, NDC 55390-138-01; UPC 3 55390-138-01 8. | Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution. | Ben Venue Laboratories Inc / 11,161 packs | Class II | Terminated |
| D-1439-2012 | 04-30-2012 | Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9 | Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates. | Apotex Inc. / 119,794 Bottles | Class II | Terminated |
| D-1423-2012 | 04-26-2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24 Package NDCs: 0280-8015-24 | Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton. | Bayer Healthcare, LLC / 119,412 cartons | Class III | Terminated |
| D-1424-2012 | 04-26-2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005-25) Package NDCs: 0280-8005-16; 0280-8005-24; 0280-8005-40; 0280-8005-01; 0280-8005-02; 0280-8005-04; 0280-8005-25 | Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton. | Bayer Healthcare, LLC / 48,528 cartons | Class III | Terminated |
| D-128-2013 | 04-24-2012 | CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88 Package NDCs: 0093-5420-88 | Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life | Teva Pharmaceuticals USA, Inc. / 13,232 bottles | Class III | Terminated |
| D-1421-2012 | 04-24-2012 | Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25 | Presence of Particulate Matter | Luitpold Pharmaceuticals, Inc. / 63,750 ampules | Class II | Terminated |
| D-004-2013 | 04-23-2012 | ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01. | Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing. | Carefusion 213, Llc / 576 Cartons | Class II | Terminated |
| D-1384-2012 | 04-23-2012 | Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66. | Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets. | Teva Pharmaceuticals USA, Inc. / 40,750 Dispensers | Class III | Terminated |
| D-037-2013 | 04-21-2012 | X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792. | Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED). | XRock Industries, LLC / 215,000 capsules | Class I | Terminated |
| D-1399-2012 | 04-17-2012 | Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01. | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc / 8254 bottles | Class III | Terminated |
| D-1403-2012 | 04-17-2012 | Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01 | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc / 7,262 bottles | Class III | Terminated |
| D-1419-2012 | 04-17-2012 | Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30 | Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL | Hospira Inc. / 212,370 cartidges | Class I | Terminated |
| D-1402-2012 | 04-17-2012 | Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01 Package NDCs: 0591-0369-01; 0591-0370-01; 0591-0371-01; 0591-0372-01 | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc / 18,902 bottles | Class III | Terminated |
| D-1401-2012 | 04-17-2012 | Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01 Package NDCs: 0591-0369-01; 0591-0370-01; 0591-0371-01; 0591-0372-01 | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc / 21,572 bottles | Class III | Terminated |
| D-1400-2012 | 04-17-2012 | Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01 Package NDCs: 0591-0369-01; 0591-0370-01; 0591-0371-01; 0591-0372-01 | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc / 106,323 bottles | Class III | Terminated |
| D-1665-2012 | 04-16-2012 | Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17. Package NDCs: 0270-5264-16; 0270-5264-17 | Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage. | Bracco Diagnostics Inc / 4,870 Vials | Class II | Terminated |
| D-1663-2012 | 04-16-2012 | Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15 Package NDCs: 0270-5164-12; 0270-5164-13; 0270-5164-14; 0270-5164-15 | Short Fill: The product is being recalled due to a potential underfill of the affected vials. | Bracco Diagnostics Inc / 47,750 vials | Class III | Terminated |
| D-1438-2012 | 04-13-2012 | Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9703-10), b) West-Ward (NDC 0143-9782-10). Package NDCs: 0143-9788-01; 0143-9788-25; 0143-9782-01; 0143-9782-10; 0143-9703-10 | Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. | West-ward Pharmaceutical Corp. / a) 74,960 vials; b) 911,070 vials | Class II | Terminated |
| D-1437-2012 | 04-13-2012 | Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25). Package NDCs: 0143-9788-01; 0143-9788-25; 0143-9782-01; 0143-9782-10; 0143-9704-25 | Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. | West-ward Pharmaceutical Corp. / a) 308,275 vials; b) 2,008,850 vials | Class II | Terminated |
| D-1382-2012 | 04-11-2012 | Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA. Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25; 0409-1511-97; 0409-1511-98; 0409-0501-97; 0409-0501-98; 0409-0010-97; 0409-0010-98 | Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel | Hospira, Inc. / a) 36,125 vials; b) 31,280 vials | Class II | Terminated |
| D-1371-2012 | 04-10-2012 | Carbon Dioxide, USP, Medical Gas, packaged in a) size EA aluminum, CGA940 (CDUSPEA), b) size E CGA 940 (CDUSPE), c) 50 lb CGA320 (CDUSP50, CD USP50S), d) size 160 liter (CD USP160LT350) cylinders, Rx only, Airgas, Puritan Medical, Distributed By: Airgas USA, LLC, Radnor, PA. | Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide. | Airgas Inc / 123 cylinders | Class II | Terminated |
| D-1434-2012 | 04-09-2012 | Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05 Package NDCs: 55111-338-30; 55111-338-01; 55111-338-05; 55111-339-30; 55111-339-01; 55111-339-05; 55111-340-30; 55111-340-01; 55111-340-05; 55111-341-30; 55111-341-01; 55111-341-05 | Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets. | Dr. Reddy's Laboratories, Inc. / 1656 bottles | Class II | Terminated |
| D-1435-2012 | 04-09-2012 | Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-127-05 | Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets | Dr. Reddy's Laboratories, Inc. / 1656 bottles | Class II | Terminated |
| D-1390-2012 | 04-05-2012 | Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24. Package NDCs: 0409-6729-41; 0409-6729-23; 0409-6729-11; 0409-6729-24; 0409-4121-01; 0409-4121-24; 0409-2050-01; 0409-2050-20; 0409-3164-01; 0409-3164-12; 0409-5239-01; 0409-5239-24 | Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate. | Hospira, Inc. / 164,568 containers | Class III | Terminated |
| D-1443-2012 | 04-05-2012 | Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1. | Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot. | Apotex Corp. / 1,749 Bottles | Class II | Terminated |
| D-1396-2012 | 04-02-2012 | Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Carton: NDC 0555-0171-78 Package NDCs: 0555-0171-88; 0555-0171-78 | Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight. | Teva Pharmaceuticals USA, Inc. / 4188 cartons (5 X 5 blisterpacks) | Class II | Terminated |
| D-001-2013 | 03-29-2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, carton barcode 6373944910. | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point. | McKesson Packaging Services / 187 cartons | Class III | Terminated |
| D-002-2013 | 03-29-2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, carton barcode 6373945010. | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point. | McKesson Packaging Services / 674 cartons | Class III | Terminated |
| D-1413-2012 | 03-22-2012 | Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3; 68968-5554-01 | Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value | Noven Pharmaceuticals, Inc. / 185,160 patches | Class II | Terminated |
| D-1380-2012 | 03-20-2012 | DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070 | Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione level. | Quadrant Chemical Corporation / 4800 bottles | Class III | Terminated |
| D-1405-2012 | 03-16-2012 | Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08 | Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay. | Ranbaxy Inc. / 2544 bottles | Class III | Terminated |
| D-1428-2012 | 03-14-2012 | Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10. | Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet. | Zydus Pharmaceuticals USA Inc / 1176 Bottles | Class II | Terminated |
| D-266-2013 | 03-10-2012 | Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS | Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug | The Menz Club, LLC / 50,000 capsules | Class I | Ongoing |
| D-041-2013 | 03-09-2012 | Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India | Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg | Aurobindo Pharma LTD / 23,616 bottles | Class II | Terminated |
| D-1422-2012 | 03-09-2012 | Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10. Package NDCs: 16571-411-10; 16571-412-10; 16571-412-50; 16571-413-05 | Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels. | Pack Pharmaceuticals / 4,848 bottles | Class III | Terminated |
| D-1398-2012 | 03-08-2012 | Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01 | Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point | Shionogi Inc. / 7230 bottles | Class II | Terminated |
| D-1395-2012 | 02-24-2012 | Thyro-Tab.075 mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, Iowa 51601. | Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval. | Lloyd Inc / 1,913,236 tablets | Class II | Terminated |
| D-1394-2012 | 02-24-2012 | Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, Iowa 51601 | Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval. | Lloyd Inc / 19,039 bottles | Class II | Terminated |
| D-1700-2012 | 02-23-2012 | Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY | Marketed Without an Approved ANDA/NDA: presence of sibutramine | www.vitaminbestbuy.com / 52 boxes | Class I | Terminated |
| D-1699-2012 | 02-23-2012 | Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., 27 Heping Road, Haikou, Henan Province, UPC 9 009900 0032328 | Marketed Without an Approved ANDA/NDA: presence of sildenafil. | www.vitaminbestbuy.com / 69 boxes | Class I | Terminated |
| D-1698-2012 | 02-23-2012 | Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet | Marketed Without an Approved ANDA/NDA: presence of sildenafil | www.vitaminbestbuy.com / 550 boxes | Class I | Terminated |
| D-221-2013 | 02-20-2012 | PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0024-08 | Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. | Physicians Total Care, Inc. / 1200 capsules | Class II | Terminated |
| D-222-2013 | 02-20-2012 | PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09 | Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. | Physicians Total Care, Inc. / 3660 capsules | Class II | Terminated |
| D-1389-2012 | 02-08-2012 | Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0 | Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole. | Physicians Total Care, Inc. / 3 bottles | Class II | Terminated |
| D-1407-2012 | 02-06-2012 | Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10 | CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices. | sanofi-aventis US, Inc. / 196,355 vials | Class II | Terminated |
| D-1408-2012 | 02-06-2012 | Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20 | CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices. | sanofi-aventis US, Inc. / 387,738 vials | Class II | Terminated |
| D-1393-2012 | 02-03-2012 | Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. | Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval. | Lloyd Inc / 19,166 bottles | Class II | Terminated |
| D-1392-2012 | 02-03-2012 | Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval. | Lloyd Inc / 1,924,297 bulk tablets | Class II | Terminated |
| D-265-2013 | 12-19-2011 | Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA | Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction | Body Basics Inc / 30,000 capsules | Class I | Terminated |
| D-1429-2012 | 12-02-2011 | Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA | A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified. | Eagle Pharmaceuticals Inc. / 19,660 vials | Class I | Terminated |
| D-1652-2012 | 11-10-2011 | Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.A. Av. Quilin 5273, Penalolen, Santiago. www.hipoglos.cl, www.laboratoriosandromaco.cl, Made in Chile, Net wt. per Tube: a) 0.18 oz (5 g), NDC: 50145-111-05; b) 2.2 oz (60 g), NDC: 50145-111-04; c) 2.5 oz (72 g), NDC: 50145-111-03; d) 3.5 oz (100 g), NDC: 50145-111-02; e) 4.2 oz (120 g), NDC: 50145-111-01. | Misbranded | Victus, Inc. / 1,535 Tubes | Class II | Terminated |
| D-1674-2012 | 11-08-2011 | ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA | Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging. | Carefusion 213, Llc / 67,775 Applicators | Class II | Terminated |
| D-1418-2012 | 10-17-2011 | Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30 | Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP. | Meda Pharmaceuticals Inc. / 478,569 Softgel Capsules (172,740 trade plus 305,829 samples). | Class II | Terminated |
| D-1440-2012 | 09-30-2011 | Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50 | Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume. | VistaPharm, Inc. / 27,221 unit dose cups | Class II | Terminated |
| D-1450-2014 | 09-27-2011 | Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01 Package NDCs: 53746-271-50; 53746-271-01; 53746-271-05; 53746-271-10; 53746-272-11; 53746-272-24; 53746-272-01; 53746-272-02; 53746-272-05 | Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg | Shamrock Medical Solutions Group LLC / 284/800 mg tablets | Class II | Terminated |
| D-1448-2014 | 09-27-2011 | metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01 | Labeling: Label Mix up; product labeled did not indicated Extended Release | Shamrock Medical Solutions Group LLC / 88/5 mg tablets | Class I | Terminated |
| D-1447-2014 | 09-27-2011 | Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36 | Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL | Shamrock Medical Solutions Group LLC / 55/1 mL/20mg/mL syringe | Class I | Terminated |
| D-1451-2014 | 09-27-2011 | Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60 | Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg | Shamrock Medical Solutions Group LLC / 99/240 mg softgel caps | Class II | Terminated |
| D-1446-2014 | 09-27-2011 | Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90 | Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules | Shamrock Medical Solutions Group LLC / 89/120 mg tablets | Class I | Terminated |
| D-1449-2014 | 09-27-2011 | Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Northstar Rx, Memphis, TN NDC 16714-586-01 | Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets | Shamrock Medical Solutions Group LLC / 99/500 mg tablets | Class II | Terminated |
| D-1379-2012 | 09-19-2011 | Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count tablets per bottle (NDC 54868-4165-0); Rx only, Mfg. By: G.D. searle LLC Div Pfizer, New York, NY 10017; Repacked & distributed by: Physicians total Care, Inc., Tulsa, OK 74146. | Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets. | Physicians Total Care, Inc. / a) 4 bottles; b) 2 bottles | Class II | Terminated |
| D-1370-2012 | 07-06-2011 | Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15 | Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point. | Bausch & Lomb, Inc. / 59,777 bottles | Class II | Terminated |
| D-1374-2012 | 07-05-2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186. | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 244,320 patches | Class II | Terminated |
| D-1375-2012 | 07-05-2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packaged in 30-count patches per box (NDC 54092-552-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186. | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 335,190 patches | Class II | Terminated |
| D-1373-2012 | 07-05-2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186. | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 242,100 patches | Class II | Terminated |
| D-1372-2012 | 07-05-2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) 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; 54092-554-30 | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 357,510 patches | Class II | Terminated |
| D-1446-2012 | 06-22-2011 | Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60. Package NDCs: 0487-9501-25; 0487-9501-03; 0487-9501-60; 0487-9501-01 | Lack of Assurance of Sterility | Nephron Pharmaceuticals Corp. / 56,028 cartons | Class II | Terminated |
| D-1667-2012 | 06-15-2011 | Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5. Package NDCs: 60505-0833-5 | CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product. | Apotex Corp. / 963,407 bottles | Class III | Terminated |
| D-196-2013 | 05-27-2011 | ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD Labs Houston, TX 77090 | Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. | A B Nutrition, Inc. / 912 bottles | Class II | Terminated |
| D-194-2013 | 05-27-2011 | PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090 | Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. | A B Nutrition, Inc. / 2980 bottles | Class II | Terminated |
| D-195-2013 | 05-27-2011 | PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090 | Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. | A B Nutrition, Inc. / 509 bottles | Class II | Terminated |
| D-301-2013 | 05-23-2011 | Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE 68581; NDC 54868-4710-0, Barcode 47101006IHD. | Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form. | Physicians Total Care, Inc. / 1 bottle | Class III | Terminated |
| D-091-2013 | 04-08-2011 | Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva Pharmaceuticals USA, Sellersville PA 18960; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6163-1. | Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results. | Physicians Total Care, Inc. / 9 bottles | Class III | Terminated |
| D-090-2013 | 04-08-2011 | Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6164-1. | Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results. | Physicians Total Care, Inc. / 5 bottles | Class III | Terminated |
| D-092-2013 | 04-08-2011 | Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6165-1. | Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results. | Physicians Total Care, Inc. / 5 Bottles | Class III | Terminated |
| D-547-2013 | 04-06-2011 | Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. | Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications. | Physicians Total Care, Inc. / 25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 bottles | Class II | Terminated |
| D-1658-2012 | 04-06-2011 | Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50 | Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume | VistaPharm, Inc. / N/A | Class II | Terminated |
| D-1391-2012 | 03-18-2011 | Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by: Physicians Total Care Inc., Tulsa, OK 74146, NDC # 54868-2913-03 | Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life | Physicians Total Care, Inc. / 60 bottles | Class II | Terminated |
| D-1378-2012 | 03-15-2011 | CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967. | Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed. | Luitpold Pharmaceuticals, Inc. / 30 mL: 2,078,800 vials; 100 mL: 167,100 vials | Class II | Terminated |
| D-011-2013 | 02-10-2011 | Earth Force, Ltd., Power Towels, QS Plus Hand Sanitizing Wipes (antiseptic), 50 pre-moistened Wipes, Manufactured by: ABC Compounding Co., Inc., P.O. Box 16247, Atlanta, GA 30321. | Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover). | Abc Compounding Company Inc / 66 rolls of wipes | Class III | Terminated |
| D-317-2013 | 02-08-2011 | Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146. | Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA). | Physicians Total Care, Inc. / 60 tablets | Class III | Terminated |
| D-1669-2012 | 01-19-2011 | METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771 | Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50," | VistaPharm, Inc. / 73,800 cups | Class III | Terminated |
| D-1385-2012 | 11-10-2010 | Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00 | Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. | Physicians Total Care, Inc / 540 tablets (9 containers of 60 tablets each) | Class I | Terminated |
| D-1386-2012 | 11-10-2010 | Morphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, OK 74146-6234, NDC 54868-4973-00 | Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. | Physicians Total Care, Inc / 600 tablets (5 containers of 120 tablets each) | Class I | Terminated |
| D-093-2013 | 10-04-2010 | Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, CA 91320; Dist. By: Physicians Total Care, Tulsa, OK 74146; NDC 54868-5673-1. | Presence of Particulate Matter: glass delamination | Physicians Total Care, Inc. / 20 vials | Class II | Terminated |
| D-192-2013 | 03-01-2010 | Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 fl oz (15 mL) bottle, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072. | Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone. | K C Pharmaceuticals Inc / 31,704 bottles | Class II | Terminated |
| D-1662-2012 | 06-14-2007 | Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3 Package NDCs: 60505-2502-1; 60505-2502-2; 60505-2502-3; 60505-2503-1; 60505-2503-2; 60505-2503-3 | Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. | Apotex Corp. / 31 | Class II | Terminated |
