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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
| D-337-2013 | 12-17-2012 | Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL | 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. / 70,000 capsules. | Class I | Terminated |
| D-334-2013 | 12-17-2012 | BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distributed By: DH Distribution Los Angeles, CA 90026. 1 count blister: UPC 705105524764, 5 count blister: UPC 736211124012, 10 count blister: UPC 736211123916. | 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. / 213,000 capsules | Class I | Terminated |
| D-335-2013 | 12-17-2012 | BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count UPC -608641933536 | 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. / 1,000 capsules. | Class I | Terminated |
| D-332-2013 | 12-17-2012 | libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253. | 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. / 610,000 capsules | Class I | Terminated |
| D-333-2013 | 12-17-2012 | libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek International, Inc. Moorpark, CA 930210 1 count blister: UPC 705105830735, 5 count blister: UPC 610585435939, 10 count blister: UPC 610585435922. | 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. / 686,000 capsules | Class I | Terminated |
| D-338-2013 | 12-17-2012 | CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova Distributors, Tucker, GA | 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. / 96,000 capsules. | Class I | Terminated |
| D-166-2013 | 12-14-2012 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21. | Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 3,407 cartons | Class I | Terminated |
| D-094-2013 | 12-13-2012 | Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880. | Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities. | Watson Laboratories Inc / 63,627 cartons | Class III | Terminated |
| D-139-2013 | 12-12-2012 | Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033 | Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring. | Schering-Plough Products, LLC / 17,169 Packages | Class II | Terminated |
| D-126-2013 | 12-12-2012 | Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25. | Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite. | Boehringer Ingelheim Roxane Inc / 3,553 bottles | Class III | Terminated |
| D-127-2013 | 12-10-2012 | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11. | Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label. | Upsher Smith Laboratories, Inc. / 11,316 bottles | Class III | Terminated |
| D-267-2013 | 12-10-2012 | WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD 57013. Manufactured by Riger Natural, S. A. Mexico. | Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac. | Brower Enterprises Inc / 17,555 Bottles | Class I | Terminated |
| D-150-2013 | 12-07-2012 | Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724. | Presence of Foreign Substance: Uncharacteristic blacks spots on tablets. | West-ward Pharmaceutical Corp. / 8,585 bottles | Class II | Terminated |
| D-177-2013 | 12-07-2012 | Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962. | Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label. | Bayer Healthcare, LLC / 1,353,420 Blister Packs | Class III | Terminated |
| D-130-2013 | 12-07-2012 | Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-10); Rx only, Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724. | Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets. | West-ward Pharmaceutical Corp. / 32,550 bottles | Class II | Terminated |
| D-131-2013 | 12-07-2012 | Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724. | Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets. | West-ward Pharmaceutical Corp. / 43,075 bottles | Class II | Terminated |
| D-138-2013 | 12-06-2012 | Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. | Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals / 897,379 bottles | Class I | Terminated |
| D-149-2013 | 12-05-2012 | PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724. | Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets. | West-ward Pharmaceutical Corp. / 128,319 bottles | Class II | Terminated |
| D-133-2013 | 12-05-2012 | PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724. | Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions. | West-ward Pharmaceutical Corp. / 60,289 bottles | Class II | Terminated |
| D-818-2013 | 12-05-2012 | Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071 | Failed impurities/degradation specifications: Purity readings for oxygen were out of specification. | Oklahoma Respiratory Care Inc / 94 cylinders | Class II | Terminated |
| D-249-2013 | 12-05-2012 | Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131; Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30 Package NDCs: 68546-317-00; 68546-317-30; 68546-325-06; 68546-325-12 | Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system. | Teva Pharmaceuticals USA, Inc. / 6,692 boxes | Class II | Terminated |
| D-107-2013 | 12-04-2012 | Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A. Package NDCs: 0074-4341-13; 0074-4341-90; 0074-4341-19; 0074-4341-72; 0074-4552-13; 0074-4552-90; 0074-4552-19; 0074-4552-11; 0074-4552-71; 0074-4552-72; 0074-5182-13; 0074-5182-90; 0074-5182-71; 0074-5182-19; 0074-5182-11; 0074-5182-72; 0074-6594-13; 0074-6594-90; 0074-6594-71; 0074-6594-19; 0074-6594-72; 0074-6624-13; 0074-6624-90; 0074-6624-19; 0074-6624-11; 0074-6624-71; 0074-6624-72; 0074-9296-13; 0074-9296-90; 0074-9296-19; 0074-9296-71; 0074-9296-72; 0074-7068-13; 0074-7068-90; 0074-7068-71; 0074-7068-19; 0074-7068-11; 0074-7068-72; 0074-3727-13; 0074-3727-90; 0074-3727-71; 0074-3727-19; 0074-3727-72; 0074-7069-90; 0074-7069-71; 0074-7069-19; 0074-7069-11; 0074-7069-72; 0074-7070-13; 0074-7070-90; 0074-7070-71; 0074-7070-19; 0074-7070-72; 0074-7148-90; 0074-7148-19; 0074-7148-71; 0074-7148-11; 0074-7148-72; 0074-7149-90; 0074-7149-19 | Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets. | Abbott Laboratories / 28, 524 bottles | Class II | Terminated |
| D-174-2013 | 12-04-2012 | Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724 | Failed Dissolution Specifications; 36 month stability timepoint | West-ward Pharmaceutical Corp. / 77531 bottles | Class II | Terminated |
| D-173-2013 | 12-04-2012 | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09 | Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. | Amedra Pharmaceuticals LLC / 10,968 bottles | Class II | Terminated |
| D-098-2013 | 12-04-2012 | Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC, Distributed in the US by: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558-9418 NDC 58232-0326-8 | Superpotent (Single Ingredient Drug): salicylic acid | Johnson & Johnson / 1,474,462 bottles | Class III | Terminated |
| D-322-2013 | 12-04-2012 | Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley Drugs, Manufactured by Green Valley Drugs, Henderson, NV. | Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV. | Green Valley Drugs / 58 x 30 ml Vials | Class I | Terminated |
| D-321-2013 | 12-04-2012 | Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL pre-filled syringes, For Office Use Only, Manufactured by Green Valley Drugs, Henderson, NV. | Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV. | Green Valley Drugs / 1395 Vials total; 900x1 ml vials 20121105-B; 90x 2ml vials of lot 20121112-G and 495x1 ml vials of lot 20121112-G. | Class I | Terminated |
| D-172-2013 | 12-04-2012 | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09 | Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. | Amedra Pharmaceuticals LLC / 12,948 bottles | Class II | Terminated |
| D-171-2013 | 12-04-2012 | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09 | Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. | Amedra Pharmaceuticals LLC / 1,176 bottles | Class II | Terminated |
| D-201-2013 | 11-30-2012 | Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01. | Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline. | West-ward Pharmaceutical Corp. / 1763 bottles | Class III | Terminated |
| D-189-2013 | 11-30-2012 | VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11 Manufactured for: VersaPharm Incorporated Marietta, GA 30062-2260, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724. | Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored. | West-ward Pharmaceutical Corp. / 18,825 bottles | Class II | Terminated |
| D-132-2013 | 11-30-2012 | Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724. | Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets. | West-ward Pharmaceutical Corp. / 43,478 bottles | Class II | Terminated |
| D-462-2014 | 11-29-2012 | NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for and Distributed by NewMarket Health Products, LLC. 702 Cathedral St. Baltimore, MD 21201 | Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications. | Mariposa Labs, LLC / 14,664 tubes | Class II | Terminated |
| D-219-2013 | 11-26-2012 | TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection and 1 vial DILUENT for TORISEL, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA --- NDC 0008-1179-01 Package NDCs: 0008-1179-01; 0008-1279-01; 0008-1125-01 | Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials. | Pfizer Inc. / 10920 kits | Class III | Terminated |
| D-086-2013 | 11-21-2012 | Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6. Package NDCs: 51672-4118-5; 51672-4118-2; 51672-4118-6 | Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples. | Taro Pharmaceuticals U.S.A., Inc. / 39,982 Tubes | Class II | Terminated |
| D-096-2013 | 11-21-2012 | Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01 Package NDCs: 0409-1463-71; 0409-1463-01; 0409-1465-71; 0409-1465-01; 0409-1464-61; 0409-1464-01; 0409-1467-61; 0409-1467-01 | Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured. | Hospira, Inc. / 145,400 vials | Class II | Terminated |
| D-157-2013 | 11-21-2012 | Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany). | Presence of Particulate Matter; fibers identified as cellulose and polyvinyl | Bracco Diagnostic Inc / 5483 syringes (548.3 boxes) | Class I | Terminated |
| D-217-2013 | 11-21-2012 | Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04 | Subpotent; 12 month stability timepoint | Hill Dermaceuticals, Inc. / 8,736 bottles | Class III | Terminated |
| D-218-2013 | 11-21-2012 | Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04 | Subpotent; 22 month stability timepoint | Hill Dermaceuticals, Inc. / 8,592 bottles | Class III | Terminated |
| D-158-2013 | 11-21-2012 | Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67. | Presence of Particulate Matter; fibers identified as cellulose and polyvinyl | Bracco Diagnostic Inc / 5736 syringes (573.6 boxes) | Class I | Terminated |
| D-160-2013 | 11-20-2012 | Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9 | Failed Dissolution Test Requirements | Upsher Smith Laboratories, Inc. / 60 bottles | Class II | Terminated |
| D-146-2013 | 11-19-2012 | EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215*** | Defective Container: Pump head detaching from the canister unit upon removal of the overcap. | Ascend Therapeutics Inc / 4, 835 bottles | Class III | Terminated |
| D-214-2013 | 11-15-2012 | Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx, Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK --- NDC 54868-4507-00 | Subpotent; 15 month stability (by mfr) | Physicians Total Care, Inc. / 90 pills | Class II | Terminated |
| D-159-2013 | 11-15-2012 | Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25; 0409-1511-97; 0409-1511-98; 0409-0501-97; 0409-0501-98; 0409-0010-97; 0409-0010-98 | Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection. | Hospira Inc. / 273,925 vials | Class II | Terminated |
| D-072-2013 | 11-09-2012 | Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05. 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 Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. | Ranbaxy Inc. / 157,026 Bottles | Class II | Terminated |
| D-070-2013 | 11-09-2012 | Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, 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 Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. | Ranbaxy Inc. / 120,201 Bottles | Class II | Terminated |
| D-071-2013 | 11-09-2012 | Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-828-90 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 Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. | Ranbaxy Inc. / 203,198 Bottles | Class II | Terminated |
| D-153-2013 | 11-08-2012 | Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56. Package NDCs: 61703-339-18; 61703-339-22; 61703-339-50; 61703-339-56 | Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. | Hospira Inc. / 23,315 vials | Class I | Completed |
| D-154-2013 | 11-08-2012 | Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, IL 60045, Product of Australia. Package NDCs: 61703-339-18; 61703-339-22; 61703-339-50; 61703-339-56; 61703-360-50 | Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. | Hospira Inc. / 31,326 vials | Class I | Completed |
| D-069-2013 | 11-08-2012 | Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12 | Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured. | Procter & Gamble Co / 17,532 bottles | Class II | Terminated |
| D-819-2013 | 11-06-2012 | VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451, Package NDCs: 65757-300-01; 65757-302-02; 65757-304-03; 65757-301-01; 65757-303-02; 65757-305-03 | Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing. | Alkermes, Inc. / 3,325 vials | Class II | Terminated |
| D-067-2013 | 11-05-2012 | Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54 | Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product | Boehringer Ingelheim Roxane Inc / 8,381 bottles | Class II | Terminated |
| D-089-2013 | 11-05-2012 | traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18. | Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg. | Caraco Pharmaceutical Laboratories, Ltd. / 2,264 bottles | Class II | Terminated |
| D-181-2013 | 11-02-2012 | ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35 Package NDCs: 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35 | CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed. | Bristol Myers Squibb Manufacturing Company / 21 blister packs | Class II | Terminated |
| D-054-2013 | 10-31-2012 | All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com | Lack of assurance of sterility | Ameridose LLC / | Class II | Terminated |
| D-055-2013 | 10-31-2012 | All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com | GMP deficiencies | Ameridose LLC / | Class II | Terminated |
| D-104-2013 | 10-29-2012 | Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR | Subpotent; 15 month stability | Alara Pharmaceutical Co / 7,432 bottles | Class II | Terminated |
| D-106-2013 | 10-25-2012 | Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01 | Presence of Particulates; may contain glass particles | Hospira Inc. / 361,600/1-mL ampules | Class II | Terminated |
