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-1428-2014 | 05-02-2014 | Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02 Package NDCs: 63323-403-01; 63323-403-02; 63323-403-04; 63323-403-10 | Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials. | Fresenius Kabi USA, LLC / 2,070,500 vials | Class II | Terminated |
| D-1427-2014 | 05-01-2014 | Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41. Package NDCs: 0054-3120-41 | Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point | Boehringer Ingelheim Roxane Inc / 5364 bottles | Class II | Terminated |
| D-1408-2014 | 05-01-2014 | Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02. Package NDCs: 0555-0952-02; 0555-0953-02 | Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing. | Teva Pharmaceuticals USA / 9,882 bottles | Class II | Terminated |
| D-1534-2014 | 04-30-2014 | Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption 30 pills /Bottle, Distributed by: Bacai, INC. www.litefitusa.com | Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to undeclared sibutramine, making it an unapproved new drug. | Bacai Inc. Dba Ky Duyen House / 14,040 softgel capsules | Class I | Terminated |
| D-1319-2014 | 04-29-2014 | Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count 5 mL vitamin C (ascorbic acid) solution diluent ampoules, and 30-count Advanced Glutathione Boosters capsules per box, Relumins Labs, 183 Locust Avenue, West Long Branch, NJ 07764, UPC 700175760302 | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims. | Flawless Beauty LLC / unknown | Class II | Completed |
| D-1321-2014 | 04-29-2014 | Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219 | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection. | Flawless Beauty LLC / unknown | Class II | Completed |
| D-1318-2014 | 04-29-2014 | Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manufactured by: Shandong Luye Pharmaceutical Co. Ltd, Yantai Shandong, PRC la Luye Pharma Subsidiary, UPC 6920425209014 | Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote. | Flawless Beauty LLC / unknown | Class II | Completed |
| D-1316-2014 | 04-29-2014 | Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-Seine Cedex, barcode *3421357* | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote. | Flawless Beauty LLC / unknown | Class II | Completed |
| D-1320-2014 | 04-29-2014 | Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., Ltd., 98 Soi Sukhumvlt 62, Yak 1, Bangchak, Prakanong, Bangkok 10260, Thailand, Reg. No. 1 A 1557/30; UPC 8 853533 000533 | Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease. | Flawless Beauty LLC / unknown | Class II | Completed |
| D-1317-2014 | 04-29-2014 | Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576 | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote. | Flawless Beauty LLC / unknown | Class II | Completed |
| D-1349-2014 | 04-29-2014 | Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402. | Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug. | Independent Nutrition Center, Inc. / a) 209 bottles and b) 8 bottles | Class II | Terminated |
| D-1385-2014 | 04-28-2014 | TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 18960. NDC 57844-713-46 | Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process. | Ferring Pharmaceuticals Inc / 129,060 cartons | Class II | Terminated |
| D-1352-2014 | 04-25-2014 | PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544 | Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution | Prestige Brands Holdings / 12,269 cases/36 bottles | Class III | Terminated |
| D-1353-2014 | 04-25-2014 | PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MULTI-SYMPTOM Cold (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL oz (118 mL) bottles, one each of DAYTIME MULTI-SYMPTOM Cold, Distributed by Medtech Products, Inc., Tarrytown, NY --- UPC 814832013523 | Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution | Prestige Brands Holdings / 17,479 cases/12 dual packs | Class III | Terminated |
| D-1616-2014 | 04-24-2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6. Package NDCs: 0591-0397-60; 0591-0397-19; 0591-0398-60 | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Actavis Laboratories, FL, Inc. / 36,538 bottles | Class II | Terminated |
| D-1617-2014 | 04-24-2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9. Package NDCs: 0591-0397-60; 0591-0397-19; 0591-0398-60 | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Actavis Laboratories, FL, Inc. / 6,041 bottles | Class II | Terminated |
| D-0293-2015 | 04-24-2014 | Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41. Package NDCs: 0338-5197-41 | Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers. | Baxter Healthcare Corp. / 19,152 Containers | Class II | Terminated |
| D-1341-2014 | 04-23-2014 | QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA. | Defective Delivery System; defective valve | Teva Pharmaceuticals USA / 461,592 canisters | Class II | Terminated |
| D-1344-2014 | 04-22-2014 | Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa. Package NDCs: 42794-018-02; 42794-018-12; 42794-018-06; 42794-019-02; 42794-019-06; 42794-019-12; 42794-020-02; 42794-020-12 | Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product. | SigmaPharm Laboratories LLC / 43,007 Bottles | Class II | Terminated |
| D-1567-2014 | 04-21-2014 | Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70. | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals / 200 Syringes | Class II | Terminated |
| D-1566-2014 | 04-21-2014 | Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48. | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals / 10/50 mL bags, 40/100 mL bags | Class I | Terminated |
| D-1568-2014 | 04-21-2014 | Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78. | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals / 5 Syringes | Class I | Terminated |
| D-1565-2014 | 04-21-2014 | Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68. | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals / 20 vials | Class I | Terminated |
| D-1282-2014 | 04-21-2014 | 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04. Package NDCs: 0338-0048-02; 0338-0048-03; 0338-0048-04; 0338-0048-05 | Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation. | Baxter Healthcare Corp. / 211,752 bottles | Class II | Terminated |
| D-1358-2014 | 04-21-2014 | Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10. Package NDCs: 0409-1559-18; 0409-1559-10; 0409-1559-19; 0409-1559-30; 0409-1560-18; 0409-1560-10; 0409-1560-19; 0409-1560-29; 0409-1582-18; 0409-1582-10; 0409-1582-19; 0409-1582-29; 0409-1587-50; 0409-1610-50; 0409-1746-70; 0409-1746-10; 0409-1746-71; 0409-1746-30; 0409-1749-70; 0409-1749-10; 0409-1749-71; 0409-1749-29; 0409-1752-50; 0409-1755-50; 0409-2510-01; 0409-2510-25; 0409-7535-01; 0409-7535-25; 0409-1250-01; 0409-1250-25; 0409-5010-01; 0409-5010-25; 0409-1530-01; 0409-1530-25; 0409-0525-01; 0409-0525-25; 0409-7510-01; 0409-7510-25; 0409-2253-01; 0409-2253-25 | Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. | Hospira Inc. / 85,680 vials | Class I | Terminated |
| D-0382-2015 | 04-18-2014 | 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02. Package NDCs: 0409-4713-12; 0409-4713-26; 0409-4713-02; 0409-4713-72; 0409-4713-62; 0409-4713-75; 0409-4713-65; 0409-4713-42; 0409-4713-25; 0409-4713-32; 0409-4278-16; 0409-4278-01; 0409-4279-16; 0409-4279-02; 0409-4776-10; 0409-4776-01; 0409-4282-11; 0409-4282-25; 0409-4282-01; 0409-4282-12; 0409-4282-02; 0409-4277-16; 0409-4277-01; 0409-4277-17; 0409-4277-02; 0409-4276-16; 0409-4276-01; 0409-4276-17; 0409-4276-02; 0409-4275-16; 0409-4275-01 | Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution. | Hospira Inc. / 120,900 vials | Class I | Terminated |
| D-1609-2014 | 04-18-2014 | Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03 | Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point. | Apotex Corp. / 5,397 bottles | Class III | Terminated |
| D-0304-2015 | 04-17-2014 | Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA . | Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point. | Wockhardt Usa Inc. / 1,118,400 extended release tablets | Class III | Terminated |
| D-1544-2014 | 04-17-2014 | Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-30, UPC 3 13811 55830 2. | Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12. | Trigen Laboratories, Inc. / 142,732 bottles | Class III | Terminated |
| D-1382-2014 | 04-17-2014 | CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6. | Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard. | Cubist Pharmaceuticals, Inc. / 51,500 vials | Class I | Terminated |
| D-1409-2014 | 04-16-2014 | Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30 Package NDCs: 0008-1211-50; 0008-1211-01; 0008-1211-14; 0008-1211-30; 0008-1222-01; 0008-1222-14; 0008-1222-30; 0008-1222-50; 0008-1210-30 | Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq. | Pfizer Us Pharmaceutical Group / 220,761 bottles | Class II | Terminated |
| D-1298-2014 | 04-15-2014 | Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105. UPC: 0 32251 03394 0. C) Good Neighbor Pharmacy. Distributed By: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087. NDC: 24385-121-25. D) Pedia Care. Distributed by Medtech Products Inc., Irvington, NY 10533. UPC: 8 14832 01354 7. E) Quality Choice. Distributed by Quality Choice, Novi, MI 48376-0995. NDC: 63868-0368-04. F) Safeway. Distributed by Safeway Inc. P.O. Box 99, Pleasanton, CA 94566. NDC: 21130-152-04. G) Well at Walgreens. Distributed By: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0152-04. | Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. | P&L Developments, LLC / 1,363,338 Bottles | Class III | Terminated |
| D-1535-2014 | 04-15-2014 | Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured for & Distributed by Nanowellbeing Health, Inc., 14747 Artesia Blvd, #5V, La Mirada, CA 90638. UPC: 7 99475 35350 5. | Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone. | Sung Soo Kim / 6,336 bottles | Class I | Terminated |
| D-1254-2014 | 04-14-2014 | Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron Health, 8 FL OZ, Manufactured by: PL Developments, 11865 S. Alameda St, Lynwood, CA 90262, UPC: 7 15256 71428 0; C) Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73506 3; D) Aaron Health, 4 FL OZ, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73504 9; E) Best Choice, 6 FL OZ, Proudly Distributed By: Valu Merchandisers, CO., Kansas City, MO 64111, UPC: 0 70038 61984 0 F) Best Choice, 10 FL OZ, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 61985; G) CareOne, 10 FL OZ, Distributed By American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31853 5; H) CareOne, 12 FL OZ, Distributed By: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31832 0; I) drug mart, 10 FL OZ, Distributed By: Discount Drug Mart-Food Fair, Medina, Ohio 44256, NDC: 93351-0142-1; J) DR, 6 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04479; K) DR, 10 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04480 6; L) equate, 10 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-01; M) equate: 12 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-02; N) exchange select, 10 FL OZ, Manufactured For: Your Military Exchanges, By Aaron Industries Inc., P.O. Box 801, Lynwood CA 90262, UPC: 6 14299 40234 8; O) Family wellness, 10 FL OZ, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105 USA, UPC: 0 32251 00504 6; P) Fred's, 10 FL OZ, Distributed By: Fred's, Inc., 4300 New Getwell Rd, Memphis, TN 38118, UPC: 0 84579 11020 9; Q) Laura Lynn, 6 FL OZ, Distributed by: Ingles Markets, Asheville, NC 28816, UPC: 0 86854 04767 5; R) LiveBetter, 10 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 49580-3416-1; S) LiveBetter, 6 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 41310-0142-6; T) Marc's, 10 FL OZ, Distributed by: Marc Glassman Inc. Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; U) 666 COLD Preparation, 4 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00224 3; V) 666 COLD Preparation, 8 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00228 1; W) Our Family, 12 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 97109 9; X) Our Family, 10 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 96745 0; Y) Premier Value, 6 FL OZ, Distributed By: Chain Drug Consortium, LLC., 2300 NW Corporate Blvd., Suite 115, Boca Rataon, FL 33431, NDC: 68016-0023-79; Z) Premier Value, 8 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-08; AA) Premier Value, 10 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-01; BB) Publix, 10 FL OZ, Distributed By: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, 0 41415 27073 2; CC) Quality Choice, 8 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novi, MI 48376, NDC: 63868-245-08; DD) Quality Choice, 10 FL OZ, Distributed by Quality Choice, Novi, MI 48376, NDC: 63868-0245-10; EE) Quality Choice, 12 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novli, MI 48376, NDC: 63868-245-12; FF) Rite Aid, 6 FL OZ, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 170 | Subpotent Drug: Phenylephrine component is subpotent. | P&L Developments, LLC / 2,500,510 bottles | Class III | Terminated |
| D-1255-2014 | 04-14-2014 | Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06 | Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith. | Upsher Smith Laboratories, Inc. / 1,185 bottles | Class III | Terminated |
| D-0247-2015 | 04-14-2014 | HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01 Package NDCs: 63323-469-01; 63323-469-05; 63323-471-01; 63323-471-05 | Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result. | Fresenius Kabi USA LLC / 216,517 vials | Class III | Terminated |
| D-1357-2014 | 04-14-2014 | LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30 | Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning | Golden State Medical Supply Inc. / 6,042 bottles | Class II | Terminated |
| D-1343-2014 | 04-14-2014 | phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02 | Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant.. | Fresenius Medical Care Holdings, Inc. / 14,496 bottles | Class II | Terminated |
| D-1286-2014 | 04-11-2014 | Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) Our Family 4 fl oz bottle, Distributed by Nash Finch Company, NFC Brands, MPLS, MN 55435, UPC 070253579523, C) Premier Value 4, 8 fl oz bottle, Distributed by Chain Drug Consortium, LLC., Boca Raton, FL 33431, 4 fl oz UPC 840986024719; 8 fl oz UPC 840986024726, NDC 68016-177-XX, D) Rexall 4 fl oz bottle, Packaged for Dolencorp, LLC, Goodlettsville, TN 37072, UPC 715256714044, E) Safeway 4 fl oz, Distributed by Safeway INC, Pleasanton, CA 94566-0009, UPC 321130763581; F) Select Brand 4, 8 fl oz, Distributed by Select Brand Distributers, Pine Bluff, AR 71603, 4 fl oz UPC 015127024303; 8 fl oz UPC 015127024310. | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. | Aaron Industries Inc / 108,792 bottles | Class III | Terminated |
| D-1411-2014 | 04-10-2014 | Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5. | Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. | Bausch & Lomb, Inc. / 35,253 tubes | Class II | Terminated |
| D-1355-2014 | 04-10-2014 | Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02. | Failed Dissolution Specifications: Failure of dissolution test observed at three month time point. | Wockhardt Usa Inc. / 8712 Bottles | Class II | Terminated |
| D-1410-2014 | 04-10-2014 | Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC 24208-385-56, UPC 3 24208-385-56 3; Bausch & Lomb Incorporated, Tampa, FL 33637. Package NDCs: 24208-385-55; 24208-385-56; 24208-385-01 | Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. | Bausch & Lomb, Inc. / a) 4,165 tubes; b) and c) 844,879 tubes | Class II | Terminated |
| D-1296-2014 | 04-09-2014 | Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83 | Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide | Caraco Pharmaceutical Laboratories, Ltd. / 128,363 bottles | Class III | Terminated |
| D-1297-2014 | 04-09-2014 | Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83 | Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide | Caraco Pharmaceutical Laboratories, Ltd. / 47,813 bottles | Class III | Terminated |
| D-1407-2014 | 04-09-2014 | Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40 | Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance. | Caraco Pharmaceutical Laboratories, Ltd. / 200 vials | Class II | Terminated |
| D-1363-2014 | 04-09-2014 | Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61 | Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets | Legacy Pharmaceutical Packaging / unknown | Class II | Terminated |
| D-1594-2014 | 04-09-2014 | THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA. | Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. | Nature's Universe / Unknown | Class I | Terminated |
| D-1253-2014 | 04-08-2014 | Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60 | Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg). | Pfizer Inc. / 23,064 bottles | Class II | Terminated |
| D-1325-2014 | 04-07-2014 | BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2. | Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. | Teva Pharmaceuticals USA / 53,452 bottles | Class II | Terminated |
| D-1324-2014 | 04-07-2014 | BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5. | Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. | Teva Pharmaceuticals USA / 17,181 bottles | Class II | Terminated |
| D-1262-2014 | 04-07-2014 | Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA 18017. NDC: 66794-015-25. Package NDCs: 66794-015-25 | Failed pH Specifications: product was too acidic. | Piramal Critical Care, Inc. / 12,600 bottles | Class II | Terminated |
| D-1314-2014 | 04-04-2014 | Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11 Package NDCs: 0054-4581-27; 0054-4581-11 | Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months. | Boehringer Ingelheim Roxane Inc / 98,560 bottles | Class III | Terminated |
| D-1313-2014 | 04-04-2014 | Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25 | Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months. | Boehringer Ingelheim Roxane Inc / 8,304 bottles | Class III | Terminated |
| D-1547-2014 | 04-02-2014 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30 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 glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution. | Hospira Inc. / 844,300 vials | Class I | Terminated |
| D-1300-2014 | 04-01-2014 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1. | Failed Dissolution Specifications: failure of dissolution test observed at nine month time point. | Wockhardt Usa Inc. / 109,744 bottles | Class II | Terminated |
| D-0048-2015 | 04-01-2014 | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702-052-16, Rx Only, Manufactured for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. | Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station. | Hi-Tech Pharmacal Co., Inc. / 451,916 bottles | Class II | Terminated |
| D-1285-2014 | 04-01-2014 | Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2 | Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser. | Genesis Pharmaceutical, Inc. / 461 Bottles | Class III | Terminated |
| D-1315-2014 | 04-01-2014 | PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10. | Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. | Konsyl Pharmaceuticals Inc / 6286 Bottles | Class III | Terminated |
| D-1499-2014 | 04-01-2014 | triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78 | Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole. | Teva Pharmaceuticals USA / 89,215 blister pack | Class II | Terminated |
| D-1602-2014 | 03-28-2014 | XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789 | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1600-2014 | 03-28-2014 | Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA 90012 | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1598-2014 | 03-28-2014 | XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012 | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1596-2014 | 03-28-2014 | AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City. | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1597-2014 | 03-28-2014 | Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering Co., Ltd, USA., | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Black Ant because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1601-2014 | 03-28-2014 | Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orlando, FL 32789 | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone 1200because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1603-2014 | 03-28-2014 | MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663 | Marketed Without an Approved NDA/ANDA; Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1599-2014 | 03-28-2014 | XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of Los Angeles, CA 90012 | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN PLATINUM because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1423-2014 | 03-28-2014 | Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709 | Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use. | United Therapeutics Corp. / 188 Units | Class II | Terminated |
| D-1261-2014 | 03-27-2014 | Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA | Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide | Hospira Inc. / 255,900 vials | Class II | Terminated |
| D-1230-2014 | 03-27-2014 | Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany. Package NDCs: 0597-0075-41; 0597-0075-75; 0597-0075-47 | Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell. | Boehringer Ingelheim Roxane Inc / 1,276,710 Blister Cards | Class III | Terminated |
| D-1362-2014 | 03-26-2014 | Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69. | Superpotent Drug: Product contains twice the stated amount of midazolam. | Pharmakon Pharmaceuticals / 80 syringes | Class I | Terminated |
| D-1226-2014 | 03-25-2014 | Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc., Lake Forest, IL. | Labeling; Missing label; ampoules are missing the immediate container label | Hospira Inc. / 237,850 ampoules | Class III | Terminated |
| D-0315-2015 | 03-25-2014 | New Life Nutritional SUPER FAT BURNER, bottle contains 30 CAPSULES, product is packaged in a white plastic bottle with black, red and green font. Distributed by: New Life Nutritional under the following addresses: 714 West 181st Street New York, NY 10033, 153 East 188th Street Bronx, NY 10468, 316 Monroe Street Passaic, NJ 07055 and 200 Dyckman Street New York, NY 10040. | Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs. | New Life Nutritional Center / 14 bottles | Class I | Terminated |
| D-0317-2015 | 03-25-2014 | Esmeralda, bottle contains 30 Softgels, product is packaged in a white plastic bottle with green labeling and black font. Distributed by: New Life Nutritional, www.newlifenutritional.com under the following addresses: 714 West 181st Street NY, NY 10033, 200-9 Dyckman Street NY, NY 10040, 153 East 188th Street Bronx, NY 10468 and 316 Monroe Street Passaic, NJ 07055. | Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs. | New Life Nutritional Center / 2 bottles | Class I | Terminated |
| D-0316-2015 | 03-25-2014 | MAXI GOLD WEIGHT LOSS PILL, bottle contains 30 CAPSULES, product is packaged in a clear plastic bottle with blue lid, gold and orange label with orange font. Distributed by: New Life nutritional, www.newlifenutritional.com under the following telephone numbers: (212) 923-6386, (212) 304-8880, (718) 329-1636 and (862) 591-2188. | Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs. | New Life Nutritional Center / 13 bottles | Class I | Terminated |
| D-1323-2014 | 03-25-2014 | Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA | First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets). | First Aid Only Inc / 802 | Class II | Terminated |
| D-1293-2014 | 03-24-2014 | GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05 | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements | Teva Pharmaceuticals USA / 2532 bottles | Class II | Terminated |
| D-1295-2014 | 03-24-2014 | INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. | Teva Pharmaceuticals USA / 5812 bottles | Class II | Terminated |
| D-1294-2014 | 03-24-2014 | INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01 | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements | Teva Pharmaceuticals USA / 7,694 bottles | Class II | Terminated |
| D1292-2014 | 03-24-2014 | METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01 | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements | Teva Pharmaceuticals USA / 22820 bottles | Class II | Terminated |
| D-1578-2014 | 03-24-2014 | PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1579-2014 | 03-24-2014 | PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3670-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1580-2014 | 03-24-2014 | PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3663-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1581-2014 | 03-24-2014 | PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3664-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1575-2014 | 03-24-2014 | PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / 13,429 bottles | Class II | Terminated |
| D-1582-2014 | 03-24-2014 | PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3666-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1574-2014 | 03-24-2014 | Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3 Package NDCs: 60505-1316-3; 60505-1317-3; 60505-1318-3; 60505-3673-3; 60505-3674-3; 60505-3675-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1576-2014 | 03-24-2014 | Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3 Package NDCs: 60505-1316-3; 60505-1317-3; 60505-1318-3; 60505-3673-3; 60505-3674-3; 60505-3675-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1577-2014 | 03-24-2014 | Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3 Package NDCs: 60505-1316-3; 60505-1317-3; 60505-1318-3; 60505-3673-3; 60505-3674-3; 60505-3675-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1354-2014 | 03-21-2014 | ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY | Non-sterility: due to a failed sterility test | Teva Pharmaceuticals USA / 47890 | Class II | Terminated |
| D-1299-2014 | 03-20-2014 | Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1. | Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point. | Apotex Inc. / 11,422 bottles | Class III | Terminated |
| D-1283-2014 | 03-20-2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. | Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications. | Caraco Pharmaceutical Laboratories, Ltd. / 160,105 bottles | Class II | Terminated |
| D-1284-2014 | 03-20-2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. | Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications. | Caraco Pharmaceutical Laboratories, Ltd. / 91,777 bottles | Class II | Terminated |
| D-1229-2014 | 03-18-2014 | Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8, NDC 68462-248-05. | Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg. | Glenmark Generics Inc., USA / 2904 bottles | Class II | Terminated |
| D-1259-2014 | 03-17-2014 | Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203. | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | John W Hollis Inc / 2 vials | Class III | Terminated |
| D-1258-2014 | 03-17-2014 | Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial, Rx Only. Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203. | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | John W Hollis Inc / 1 vial | Class III | Terminated |
| D-1257-2014 | 03-17-2014 | Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203. | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | John W Hollis Inc / 7 vials | Class II | Terminated |
| D-1260-2014 | 03-17-2014 | Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203. | Presence of Particulate Matter | John W Hollis Inc / 3 vials | Class II | Terminated |
| D-1251-2014 | 03-14-2014 | VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04. Package NDCs: 54092-701-04 | Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate. | Shire Human Genetic Therapies, Inc. / 8359 vials | Class I | Terminated |
| D-1322-2014 | 03-13-2014 | REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original. | Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol. | Pain Free By Nature / 7,123 bottles | Class I | Terminated |
