FDA Recall
Terminated
Historical recordClass II
Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026
by Dermamedics, L.L.C.
- Reason
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.
by Boehringer Ingelheim Roxane Inc
- Reason
- Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC
by Mckesson Packaging Services
- Reason
- Failed Dissolution Specification; at the 12 month time interval.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France
by Estee Lauder Inc
- Reason
- Stability Data Does Not Support Expiry
- Published
- July 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.
by Sandoz Inc
- Reason
- Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
- Published
- July 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.
by X-Gen Pharmaceuticals Inc.
- Reason
- Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".
- Published
- July 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70
by Pfizer Inc.
- Reason
- Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
by CareFusion 213, LLC
- Reason
- Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.
by Fougera Pharmaceuticals Inc.
- Reason
- Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.
by Fougera Pharmaceuticals Inc.
- Reason
- Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: out of specification impurity test results.
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: out of specification impurity test results.
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: out of specification impurity test results.
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: out of specification impurity test results.
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA
by Axcentria Pharmaceuticals, LLC
- Reason
- Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-515-16.
by Poly Pharmaceuticals, Inc
- Reason
- Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-713-16.
by Poly Pharmaceuticals, Inc
- Reason
- Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
- Published
- July 23, 2014
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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