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-1301-2014 | 03-13-2014 | Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05 | Defective container: Product distributed without inner seal on bottles. | Blu Pharmaceuticals Inc / 14,000 tablets | Class II | Terminated |
| D-1302-2014 | 03-13-2014 | Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05 | Defective container: Product distributed without inner seal on bottles. | Blu Pharmaceuticals Inc / 101,500 tablets | Class II | Terminated |
| D-1168-2014 | 03-11-2014 | Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01 | Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml. | Paddock Laboratories, LLC / 156,012 bottles | Class II | Terminated |
| D-1290-2014 | 03-10-2014 | Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-Month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3663-03, UPC 3 00743 66303 7. Package NDCs: 0074-3663-03 | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. | AbbVie Inc / 1,530 kits | Class II | Terminated |
| D-1289-2014 | 03-10-2014 | LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3779-03, UPC 3 00743 77903 5. Package NDCs: 0074-2108-03; 0074-2282-03; 0074-2440-03; 0074-3779-03; 0074-9694-03; 0074-3575-01; 0074-3410-01; 0074-0010-01 | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. | AbbVie Inc / 12 kits | Class II | Terminated |
| D-1288-2014 | 03-10-2014 | Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 45 mg for 6-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3473-03, UPC 3 00743 47303 2. Package NDCs: 0074-3473-03; 0074-3473-55; 0074-9945-01; 0074-0009-01; 0074-3683-03; 0074-3683-55; 0074-9930-01; 0074-3642-03; 0074-3642-55; 0074-9907-01; 0074-3346-03; 0074-3346-55; 0074-9922-01 | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. | AbbVie Inc / 36 kits | Class II | Terminated |
| D-1287-2014 | 03-10-2014 | Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3346-03, UPC 3 00743 34603 9. Package NDCs: 0074-3473-03; 0074-3473-55; 0074-9945-01; 0074-0009-01; 0074-3683-03; 0074-3683-55; 0074-9930-01; 0074-3642-03; 0074-3642-55; 0074-9907-01; 0074-3346-03; 0074-3346-55; 0074-9922-01 | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. | AbbVie Inc / 7362 kits | Class II | Terminated |
| D-1291-2014 | 03-10-2014 | Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 7.5 mg for 1-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3642-03, UPC 3 00743 64203 2. Package NDCs: 0074-3473-03; 0074-3473-55; 0074-9945-01; 0074-0009-01; 0074-3683-03; 0074-3683-55; 0074-9930-01; 0074-3642-03; 0074-3642-55; 0074-9907-01; 0074-3346-03; 0074-3346-55; 0074-9922-01 | Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device. | AbbVie Inc / 2915 kits | Class II | Terminated |
| D-1328-2014 | 03-06-2014 | Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101. | Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule. | Pfizer Us Pharmaceutical Group / 49,847 bottles | Class I | Terminated |
| D-1361-2014 | 03-06-2014 | Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9. | Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot | Greenstone Llc / 16,018 bottles | Class I | Terminated |
| D-1182-2014 | 03-04-2014 | Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06 | Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. | Teva Pharmaceuticals USA / 127,585 Bottles | Class II | Terminated |
| D-1183-2014 | 03-04-2014 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7543-56 | Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. | Teva Pharmaceuticals USA / 598,033 Bottles | Class II | Terminated |
| D-1184-2014 | 03-04-2014 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7544-56 | Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. | Teva Pharmaceuticals USA / 324,648 Bottles | Class II | Terminated |
| D-1556-2014 | 03-04-2014 | VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial 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 | Customer complaints for failure to deliver the dose. | Alkermes, Inc. / 4,364 vials | Class II | Terminated |
| D-1615-2014 | 03-04-2014 | Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82 Package NDCs: 25021-830-82; 25021-830-87 | Lack of Assurance of Sterility; leaking of premix bags | Sagent Pharmaceuticals Inc / 10,622 bags | Class II | Terminated |
| D-1228-2014 | 03-03-2014 | Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901 Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0441-05 | Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t | Novartis Pharmaceuticals Corp. / 10,781 bottles | Class III | Terminated |
| D-1227-2014 | 03-03-2014 | Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901, Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0440-05 | Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t | Novartis Pharmaceuticals Corp. / 10,930 Bottles | Class III | Terminated |
| D-1197-2014 | 03-03-2014 | Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-2 . | Penicillin Cross Contamination | Terra-Medica Inc. / 55 10 x 1 mL Cartons; 51 50 x 1 mL Cartons | Class II | Terminated |
| D-1212-2014 | 03-03-2014 | Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-0011-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 428 bottles | Class II | Terminated |
| D-1209-2014 | 03-03-2014 | Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1001-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 5940 Packages | Class II | Terminated |
| D-1193-2014 | 03-03-2014 | Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 7408 cartons | Class II | Terminated |
| D-1210-2014 | 03-03-2014 | Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 3440 bottles | Class II | Terminated |
| D-1192-2014 | 03-03-2014 | Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2304-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 4860 cartons | Class II | Terminated |
| D-1208-2014 | 03-03-2014 | Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1102-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 4770 Cartons | Class II | Terminated |
| D-1206-2014 | 03-03-2014 | Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-1. Pleo Fort PORTABLE SIPS 5X, 50 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-2. | Penicillin Cross Contamination. | Terra-Medica Inc. / 126 10 x 1 ml Cartons; 76 50 x 1ml Cartons | Class II | Terminated |
| D-1199-2014 | 03-03-2014 | Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Made in Germany, Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, Hoya, Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. NDC: 49807-0031-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 6120 cartons | Class II | Terminated |
| D-1191-2014 | 03-03-2014 | Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2305-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 1368 tubes | Class II | Terminated |
| D-1203-2014 | 03-03-2014 | Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-1. Pleo Quent PORTABLE SIPS 5X, 50 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-2. | Penicillin Cross Contamination | Terra-Medica Inc. / 211 10 x 1 ml vials; 152 50 x 1 vials | Class II | Terminated |
| D-1195-2014 | 03-03-2014 | Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2301-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 21,445 Bottles | Class II | Terminated |
| D-1202-2014 | 03-03-2014 | Pleo Quent DROPS 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2901-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 10,725 bottles | Class II | Terminated |
| D-1204-2014 | 03-03-2014 | Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1106-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 2147 cartons | Class II | Terminated |
| D-1211-2014 | 03-03-2014 | Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-2. | Penicillin Cross Contamination | Terra-Medica Inc. / 111 10 x 1 mls; 39 50 x 1 mls | Class II | Terminated |
| D-1198-2014 | 03-03-2014 | Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-1. Pleo Not PORTABLE SIPS 7X, 50 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-2. | Penicillin Cross Contamination | Terra-Medica Inc. / 32 10 x 1 mL Cartons; 14 50 x 1 mL Cartons | Class II | Terminated |
| D-1201-2014 | 03-03-2014 | Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG NDC: 49807-2902-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 3066 cartons | Class II | Terminated |
| D-1194-2014 | 03-03-2014 | Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2302-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 4955 cartons | Class II | Terminated |
| D-1205-2014 | 03-03-2014 | Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1103-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 4050 cartons | Class II | Terminated |
| D-1207-2014 | 03-03-2014 | Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1101-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 8405 bottles | Class II | Terminated |
| D-1200-2014 | 03-03-2014 | Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2904-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 3725 cartons | Class II | Terminated |
| D-1196-2014 | 03-03-2014 | Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-2. | Penicillin Cross Contamination | Terra-Medica Inc. / 730 10 x 1mL Cartons; 367 50 x 1 mL Cartons | Class II | Terminated |
| D-1167-2014 | 03-03-2014 | Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10 | Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval. | McKesson Packaging Services / 1,557 Boxes | Class III | Terminated |
| D-0003-2015 | 02-26-2014 | All sterile drugs compounded between 2/21/14 and 2/24/14. | Lack of Assurance of Sterility: All compounded products. | New England Home Therapies, Inc / 87 Products | Class II | Terminated |
| D-1166-2014 | 02-26-2014 | Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43 Package NDCs: 0573-0164-33; 0573-0164-04; 0573-0164-20; 0573-0164-30; 0573-0164-40; 0573-0164-43; 0573-0164-45; 0573-0164-32; 0573-0164-41; 0573-0164-91; 0573-0164-05; 0573-0164-55; 0573-0164-21; 0573-0164-44; 0573-0164-14; 0573-0164-12; 0573-0164-49; 0573-0164-46; 0573-0164-65; 0573-0164-08; 0573-0164-09 | Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate. | Pfizer Us Pharmaceutical Group / 70,704 bottles | Class III | Terminated |
| D-1245-2014 | 02-20-2014 | Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03. Package NDCs: 0135-0508-02; 0135-0508-03; 0135-0508-04; 0135-0509-02; 0135-0509-03; 0135-0509-04; 0125-0508-03 | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 834,072 81 ct Vials, 414,500 20 ct Vials, 9456 135 ct Vials | Class III | Terminated |
| D-1239-2014 | 02-20-2014 | Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01. | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 304,332 72 Ct Vials, 85,080 81 Ct Vials 22,992 108 Ct Vials | Class III | Terminated |
| D-1243-2014 | 02-20-2014 | Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03. | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 146,424 81 Ct. Vials, 105,091 189 Ct Vials | Class III | Terminated |
| D-1242-2014 | 02-20-2014 | Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03. | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 147,684 81 Ct Vials, 130564 189 Ct Vials | Class III | Terminated |
| D-1240-2014 | 02-20-2014 | Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07. Package NDCs: 0135-0510-01; 0135-0510-06; 0135-0510-07; 0135-0511-01; 0135-0511-06; 0135-0511-07; 0135-0515-03; 30142-862-01; 0363-0209-01; 0363-0209-07 | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 603,696 72 Ct Vials, 191,040 108 Ct Vials | Class III | Terminated |
| D-1246-2014 | 02-20-2014 | Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02. Package NDCs: 0135-0508-02; 0135-0508-03; 0135-0508-04; 0135-0509-02; 0135-0509-03; 0135-0509-04 | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 189,900 20 ct Vials, 145,068 81 ct Vials | Class III | Terminated |
| D-1244-2014 | 02-20-2014 | Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2. | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 12,162 Pallets | Class III | Terminated |
| D-1247-2014 | 02-20-2014 | Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2. | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 150 cases | Class III | Terminated |
| D-1241-2014 | 02-20-2014 | Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07. Package NDCs: 0135-0510-01; 0135-0510-06; 0135-0510-07; 0135-0511-01; 0135-0511-06; 0135-0511-07; 0135-0514-03; 30142-861-01; 0363-0208-07 | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 488,628 72 Ct Vial, 255,594 108 Ct Vial | Class III | Terminated |
| D-1238-2014 | 02-20-2014 | Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0446-01. | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline / 109,848 72 Ct Vials, 61,332 81 Ct Vials, 16,218 108 Ct Vials | Class III | Terminated |
| D-1090-2014 | 02-19-2014 | Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only. Manufactured for: Bristol-Myers Squibb & Gilead Sciences, LLC, Foster City, CA 94404. Made in Ireland. NDC 15584-0101-1. Manufactured for: Bristol-Myers-Squibb & Gilead Sciences, LLC, Foster City, CA 94404 Made in Ireland | Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug. | Gilead Sciences, Inc. / 39,223 bottles | Class III | Terminated |
| D-1279-2014 | 02-14-2014 | Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5. Package NDCs: 68645-131-54; 68645-130-54 | Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor. | Legacy Pharmaceutical Packaging / 667,068 bottles | Class II | Terminated |
| D-1225-2014 | 02-14-2014 | etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer Labs; Division of Pfizer Inc., New York, NY 10017. | Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials. | Agila Specialties Private Ltd. / 7919 cartons | Class II | Terminated |
| D-1326-2014 | 02-14-2014 | Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02 | Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution | Ben Venue Laboratories Inc / 5,131 vials | Class I | Terminated |
| D-0674-2016 | 02-14-2014 | CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by Medisca Inc. Plattsburgh, NY 12901, USA, NDC #s: 38779-1186-4 (25 g), 38779-1186-5 (100 g), 38779-1186-8 (500 g), 38779-1186-9 (1 kg). | Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead. | Medisca Inc / 25 g: 15 bottles, 100 g: 153 bottles; 500 g: 18 bottles, 1 kg: 24 bottles | Class I | Terminated |
| D-1422-2014 | 02-13-2014 | BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas 77478, NDC 75901-7210-53. | Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial. | Healix Infusion Therapy, Inc. / 10 bags | Class II | Terminated |
| D-1172-2014 | 02-13-2014 | Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5555-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained. | Noven Pharmaceuticals, Inc. / 117,600 patches | Class II | Terminated |
| D-1171-2014 | 02-13-2014 | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained. | Noven Pharmaceuticals, Inc. / 187,860 patches | Class II | Terminated |
| D-1281-2014 | 02-12-2014 | Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5. Package NDCs: 50111-647-01; 50111-647-02; 50111-647-03; 50111-648-01; 50111-648-02; 50111-648-03; 50111-648-44 | Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. | Teva Pharmaceuticals USA / 72,356 bottles | Class II | Terminated |
| D-1280-2014 | 02-12-2014 | Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. Package NDCs: 50111-647-01; 50111-647-02; 50111-647-03; 50111-648-01; 50111-648-02; 50111-648-03; 50111-648-44 | Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. | Teva Pharmaceuticals USA / 257904 bottles | Class II | Terminated |
| D-1185-2014 | 02-11-2014 | Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13 | Cross Contamination with Other Products: Product contains Promacta (eltrombopag). | Viiv Healthcare Company / 1,056 bottles | Class III | Terminated |
| D-1276-2014 | 02-11-2014 | Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11 Package NDCs: 0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0427-52; 0941-0427-53; 0941-0429-52; 0941-0429-53; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0484-01; 0941-0487-01; 0941-0490-01 | Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch. | Baxter Healthcare Corp. / 27,169 containers | Class I | Terminated |
| D-1096-2014 | 02-11-2014 | 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09 | Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection. | Hospira Inc. / 603,768 bags | Class II | Terminated |
| D-1190-2014 | 02-11-2014 | QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324. | Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point | Teva Pharmaceuticals USA / 257,832 cylinders | Class III | Terminated |
| D-1157-2014 | 02-10-2014 | Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75 Package NDCs: 76128-155-75 | Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014. | Pinnacle Biologics Inc / 261 vials | Class III | Terminated |
| D-1147-2014 | 02-10-2014 | Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02 Package NDCs: 0409-1159-18; 0409-1159-01; 0409-1159-19; 0409-1159-02; 0409-1160-18; 0409-1160-01; 0409-1162-18; 0409-1162-01; 0409-1162-19; 0409-1162-02; 0409-1163-18; 0409-1163-01; 0409-1165-18; 0409-1165-01; 0409-1165-19; 0409-1165-02; 0409-9043-11; 0409-9043-01; 0409-9046-11; 0409-9046-01; 0409-9045-11; 0409-9045-01; 0409-9045-16; 0409-9045-17; 0409-9042-11; 0409-9042-01; 0409-9042-16; 0409-9042-17 | Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial. | Hospira Inc. / 115,500 Vials | Class II | Terminated |
| D-1153-2014 | 02-10-2014 | Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50 Package NDCs: 0228-2027-10; 0228-2027-50; 0228-2027-96; 0228-2029-10; 0228-2029-50; 0228-2029-96; 0228-2031-10; 0228-2031-50; 0228-2031-96; 0228-2039-10 | Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg. | Actavis Elizabeth LLC / 9447 Bottles | Class II | Terminated |
| D-1256-2014 | 02-07-2014 | Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only. Labeled A) CVS Allergy Relief - D, Pseudoephedrine, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, 5-count box Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02805 UPC 050428049631 B) Discount Drug Mart Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Loratadine, USP 10 mg/Antihistamine Pseudephrine Sulfate, USP 240 mg/Nasal Decongestant Extended Release Tablets, 15-count box Distributed by Drug Mart-Food Fair Medina, Ohio 44256 UPC 093351116285 C) Kroger Non-Drowsy Allergy and Congestion Loratadine and Pseudoephedrine Extended Release Tablets Pseudoephedrine Sulfate, USP 240 mg Nasal Decongestant Loratadine, USP 10 mg, Antihistamine 10- count box, Distributed by The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-0724-69. D) Sunmark Allergy & Congestion Lorata*dine D Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, Indoor & Outdoor Allergies, Non-Drowsy 10- count box, Distributed by Mckesson One Post Street, San Francisco, CA 94104 NDC 49348-543-01 E) Good Neighbor Pharmacy Non-Drowsy Allergy and Congestion Relief pseudoephedrine sulfate, USP 240 mg/nasal decongestant loratadine, USP 10 mg/antihistamine Indoor & Outdoor Allergies Extended-Release Tablets, 10- count box, Distributed by Amerisource Bergen 1300 Morris Drive, Chesterbrook, PA 19087 NDC46122-0167-52 F) H-E-B Allergy Relief - D Non-Drowsy- 24 Hour Formula Loratadine, USP 10mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/Nasal Decogestant Indoor & Outdoor Allegies, Allergy & Congestion Extended-Release Tablets 10-count box, Distributed by H-E-B San Antonio, TX 78204 NDC 37808-0724-69 G) Rite Aid Pharmacy allergy relief & nasal decongestant loratadine USP, 10 mg, pseudoephedribe sulfate USP, 240 mg, antihistamine & nasal degestant, extended release tablets, 10- count box, Distributed by: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 UPC 0118223315555 Package NDCs: 49348-543-01; 49348-543-57; 0504280496; 0933511162; 30142-0724-69; 46122-0167-52; 37808-0724-69; 0118223315 | Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg. | Ohm Laboratories, Inc. / 29,790 blister packs | Class II | Terminated |
| D-1088-2014 | 02-07-2014 | Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77. | Subpotent Drug: Drug potency was compromised during shipment. | Actavis / 38,227 Clamshells | Class III | Terminated |
| D-1097-2014 | 02-04-2014 | Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3. | Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out. | Aaron Industries Inc / 43,921 bottles | Class III | Terminated |
| D-1091-2014 | 02-04-2014 | Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2. | Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. | Actavis Elizabeth LLC / 5,148 bottles | Class II | Terminated |
| D-1177-2014 | 01-31-2014 | ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04 Package NDCs: 68791-102-04; 68791-102-01 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 7,292 bottles | Class III | Terminated |
| D-1176-2014 | 01-31-2014 | ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04 Package NDCs: 68791-101-04; 68791-101-01 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 8,734 bottles | Class III | Terminated |
| D-1181-2014 | 01-31-2014 | SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 13,591 bottles | Class III | Terminated |
| D-1178-2014 | 01-31-2014 | ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20 Package NDCs: 68791-103-20 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 13,379 bottles | Class III | Terminated |
| D-1179-2014 | 01-31-2014 | SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 4,142 bottles | Class III | Terminated |
| D-1173-2014 | 01-31-2014 | DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 4,080 bottles | Class III | Terminated |
| D-1174-2014 | 01-31-2014 | Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 14,226 bottles | Class III | Terminated |
| D-1188-2014 | 01-31-2014 | HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01 | Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. | American Health Packaging / 14,665 blister packs | Class II | Terminated |
| D-1189-2014 | 01-31-2014 | HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01 | Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. | American Health Packaging / 8,570 blister packs | Class II | Terminated |
| D-1180-2014 | 01-31-2014 | SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 7,676 bottles | Class III | Terminated |
| D-1175-2014 | 01-31-2014 | Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04 | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 8,734 bottles | Class III | Terminated |
| D-1081-2014 | 01-29-2014 | Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. NDC 62756-184-88, Rx only, 100 Tablets; Pharmacist: Dispense the Medication Guide provided separately to each patient. Each film-coated tablet contains 300 mg oxcarbazepine, USP, Usual Dosage: See package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted.... Distributed by Caraco Pharmaceuticals Detroit, MI.... Package NDCs: 62756-183-83; 62756-183-88; 62756-183-08; 62756-183-13; 62756-183-18; 62756-184-83; 62756-184-88; 62756-184-08; 62756-184-13; 62756-184-18; 62756-185-83; 62756-185-88; 62756-185-08; 62756-185-13; 62756-185-18 | Failed Tablet Specifications: Broken Tablets Present. | Caraco Pharmaceutical Laboratories Ltd. / 7005 bottles | Class II | Terminated |
| D-1356-2014 | 01-29-2014 | GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1 Package NDCs: 59762-5015-1; 59762-5016-1; 59762-5017-1; 59762-5018-1; 59762-5029-1; 59762-5030-1 | Defective Container: Tamper evident ring failures discovered on some bottles. | Pfizer Inc. / 4,155 bottles | Class II | Terminated |
| D-1152-2014 | 01-29-2014 | Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8. Package NDCs: 0168-0003-15; 0168-0003-80; 0168-0004-15; 0168-0004-80; 0168-0004-16; 0168-0002-15 | Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%. | Fougera Pharmaceuticals Inc. / 493,192 tubes | Class III | Terminated |
| D-1089-2014 | 01-28-2014 | Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02 Package NDCs: 62756-142-01; 62756-142-02; 62756-143-01 | Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER | Caraco Pharmaceutical Laboratories, Ltd. / 2528 bottles | Class II | Terminated |
| D-1155-2014 | 01-28-2014 | Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20 | Failed Impurity/degradation Specification | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 3,252 cartons | Class III | Terminated |
| D-1164-2014 | 01-28-2014 | Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831*** | Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping | RX South LLC DBA RX3 Pharmacy / 250 syringes | Class II | Terminated |
| D-1186-2014 | 01-27-2014 | Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02. | Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station. | Lupin Pharmaceuticals Inc. / 4,038 bottles | Class III | Terminated |
| D-1187-2014 | 01-27-2014 | Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-03. | Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station. | Lupin Pharmaceuticals Inc. / 5,172 bottles | Class III | Terminated |
| D-1093-2014 | 01-24-2014 | Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02 Package NDCs: 0555-0323-02; 0555-0323-04; 0555-0302-02; 0555-0302-04; 0555-0324-02 | CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. | Teva Pharmaceuticals USA / 2494 capsules | Class II | Terminated |
| D-1095-2014 | 01-24-2014 | Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02. Package NDCs: 0555-0323-02; 0555-0323-04; 0555-0302-02; 0555-0302-04; 0555-0324-02 | CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. | Teva Pharmaceuticals USA / 35746 capsules | Class II | Terminated |
| D-1094-2014 | 01-24-2014 | Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02. Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment. | Teva Pharmaceuticals USA / 9796 tablets | Class II | Terminated |
| D-1376-2014 | 01-24-2014 | SlimEasy Herbs Capsule, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine | MyNicNaxs, Inc. / 2 boxes | Class I | Terminated |
| D-1092-2014 | 01-24-2014 | Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02. | CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation. | Teva Pharmaceuticals USA / 10405 tablets | Class II | Terminated |
| D-1377-2014 | 01-24-2014 | Meizi Evolution Soft Gel Capsules, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine | MyNicNaxs, Inc. / 5 bottles | Class I | Terminated |
| D-1373-2014 | 01-24-2014 | Fruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein . | MyNicNaxs, Inc. / 2 boxes | Class I | Terminated |
| D-1374-2014 | 01-24-2014 | Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine | MyNicNaxs, Inc. / unknown | Class I | Terminated |
