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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0564-2018 | 03-07-2017 | STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class II | Terminated |
| D-0567-2018 | 03-07-2017 | YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0607-2017 | 03-07-2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-10). | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius. | Pfizer Inc / 28,938 units | Class III | Terminated |
| D-0608-2017 | 03-07-2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-205-25). | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius. | Pfizer Inc / 11,862 units | Class III | Terminated |
| D-0609-2017 | 03-07-2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-30). | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius. | Pfizer Inc / 9,666 units | Class III | Terminated |
| D-0554-2018 | 03-07-2017 | Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0555-2018 | 03-07-2017 | GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0572-2018 | 03-07-2017 | Tiger King tablets, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class II | Terminated |
| D-0553-2018 | 03-07-2017 | Indian God Lotion Spray Bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class III | Terminated |
| D-0606-2017 | 03-07-2017 | ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH 45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045; NDC 68645-493-54. | Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet. | Legacy Pharmaceutical Packaging LLC / 48,012 bottles | Class II | Terminated |
| D-0559-2018 | 03-07-2017 | GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0568-2018 | 03-07-2017 | Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0558-2018 | 03-07-2017 | LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0566-2018 | 03-07-2017 | HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0561-2018 | 03-07-2017 | Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class II | Terminated |
| D-0571-2018 | 03-07-2017 | MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0605-2017 | 03-06-2017 | ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. Package NDCs: 68382-022-16; 68382-022-01; 68382-022-10; 68382-022-40; 68382-022-24; 68382-023-16; 68382-023-01; 68382-023-10; 68382-023-02; 68382-023-40; 68382-023-24; 68382-024-16; 68382-024-01; 68382-024-10; 68382-024-40 | Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet. | Zydus Pharmaceuticals USA Inc / 9561 bottles | Class II | Terminated |
| D-0649-2017 | 03-06-2017 | RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-352-60 Package NDCs: 55111-352-30; 55111-352-60; 55111-352-01; 55111-352-05; 55111-353-30; 55111-353-60; 55111-353-01; 55111-353-05; 55111-354-30; 55111-354-60; 55111-354-01; 55111-354-05; 55111-355-30; 55111-355-60; 55111-355-01; 55111-355-05 | Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine. | Dr. Reddy's Laboratories, Inc. / 1,728 bottles | Class III | Terminated |
| D-0624-2017 | 03-06-2017 | Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2 Package NDCs: 0135-0548-02; 0135-0548-01; 0135-0547-02; 0135-0575-01 | Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent | GSK Consumer Healthcare / 56,840 cases | Class II | Terminated |
| D-0612-2017 | 03-02-2017 | Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60 | Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream | Fougera Pharmaceuticals Inc. / 14,665 tubes | Class II | Terminated |
| D-0662-2017 | 03-01-2017 | Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectrum SPF 30+, (Octinoxate 7.725%, Oxybenzone 6.18%, Octisalate 5.15%, Avobenzone 3.09%), Net Wt. 1.8 oz. (51 g) jar, Distributed by Signature Club A, Ltd, Tampa, FL 33609. | Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination. | Signature Club A Ltd / 1,237 jars | Class II | Ongoing |
| D-0519-2017 | 02-28-2017 | Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road, Lincolnton, NC 28092. | CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots. | G & W Laboratories, Inc. / 39,816 bottles | Class III | Terminated |
| D-0652-2017 | 02-24-2017 | Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ --- NDC 57237-041-99 Package NDCs: 57237-040-01; 57237-040-99; 57237-041-01; 57237-041-05; 57237-041-99 | Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg | Citron Pharma Llc / 420 bottles | Class III | Terminated |
| D-0513-2017 | 02-23-2017 | Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01. | Presence of Foreign Substance: foreign material found in the bulk inventory. | Mckesson Packaging Services / 6,717 cartons | Class II | Completed |
| D-0512-2017 | 02-22-2017 | Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02. Package NDCs: 52244-010-02; 52244-010-06; 52244-020-02; 52244-020-06; 52244-040-02; 52244-040-06 | Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks | Endo Pharmaceuticals, Inc. / 5,086 cartridges | Class II | Terminated |
| D-0653-2017 | 02-22-2017 | Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60 Package NDCs: 43386-069-60 | Chemical Contamination | Novel Laboratories, Inc. / 7,656 bottles | Class III | Terminated |
| D-0823-2017 | 02-22-2017 | 0.9% Sodium Chloride Slip Tip all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0829-2017 | 02-22-2017 | Calcium Gluconate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0838-2017 | 02-22-2017 | Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0835-2017 | 02-22-2017 | Rocuronium Bromide all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0846-2017 | 02-22-2017 | Dexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0843-2017 | 02-22-2017 | Ondansetron HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0797-2017 | 02-22-2017 | Nalbuphine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0809-2017 | 02-22-2017 | Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0840-2017 | 02-22-2017 | Atropine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0801-2017 | 02-22-2017 | Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0827-2017 | 02-22-2017 | Norepinephrine Bitartrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0799-2017 | 02-22-2017 | NOVA PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0824-2017 | 02-22-2017 | Diltiazem HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0825-2017 | 02-22-2017 | Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0806-2017 | 02-22-2017 | Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0834-2017 | 02-22-2017 | Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0848-2017 | 02-22-2017 | Magnesium Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0804-2017 | 02-22-2017 | Standard Starter TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0814-2017 | 02-22-2017 | Midazolam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0849-2017 | 02-22-2017 | Potassium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0802-2017 | 02-22-2017 | NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0795-2017 | 02-22-2017 | Ropivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0833-2017 | 02-22-2017 | Nitroglycerin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0836-2017 | 02-22-2017 | Labetalol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0831-2017 | 02-22-2017 | Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0818-2017 | 02-22-2017 | Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0820-2017 | 02-22-2017 | Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0826-2017 | 02-22-2017 | Ephedrine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0830-2017 | 02-22-2017 | Amiodarone all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0796-2017 | 02-22-2017 | Lidocaine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0816-2017 | 02-22-2017 | Methohexital Sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0845-2017 | 02-22-2017 | Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0819-2017 | 02-22-2017 | Penicillin G Potassium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0852-2017 | 02-22-2017 | Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0815-2017 | 02-22-2017 | Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0844-2017 | 02-22-2017 | Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0805-2017 | 02-22-2017 | Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0850-2017 | 02-22-2017 | Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0808-2017 | 02-22-2017 | Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0822-2017 | 02-22-2017 | Heparin sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0841-2017 | 02-22-2017 | Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0839-2017 | 02-22-2017 | Neostigmine Methylsulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0798-2017 | 02-22-2017 | RECK PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0807-2017 | 02-22-2017 | ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0811-2017 | 02-22-2017 | Meperidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0813-2017 | 02-22-2017 | Ketamine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0800-2017 | 02-22-2017 | Ofirmev (Acetaminophen) injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0853-2017 | 02-22-2017 | Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0851-2017 | 02-22-2017 | Sodium Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0803-2017 | 02-22-2017 | TPN Neonatal all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0794-2017 | 02-22-2017 | Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0847-2017 | 02-22-2017 | Cardioplegic Solution Maintenance all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0821-2017 | 02-22-2017 | Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0817-2017 | 02-22-2017 | Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0810-2017 | 02-22-2017 | Hydromorphone HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0832-2017 | 02-22-2017 | Adenosine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0837-2017 | 02-22-2017 | Esmolol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0812-2017 | 02-22-2017 | Morphine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0842-2017 | 02-22-2017 | Famotidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0828-2017 | 02-22-2017 | Epinephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0604-2017 | 02-21-2017 | A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981 | Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue. | Bayer HealthCare Pharmaceuticals, Inc. / a) 468,576 (1.5g); b) 203868 (3 oz) and c) 802,620 (4 oz) | Class III | Terminated |
| D-0914-2017 | 02-17-2017 | VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 816 bags | Class II | Terminated |
| D-0906-2017 | 02-17-2017 | Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 216 bags | Class III | Terminated |
| D-0915-2017 | 02-17-2017 | VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 60 bags | Class II | Terminated |
| D-0909-2017 | 02-17-2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 192 bags | Class III | Terminated |
| D-0911-2017 | 02-17-2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 672 bags | Class III | Terminated |
| D-0511-2017 | 02-17-2017 | Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. | Failed Dissolution Specifications: low out of specification dissolution results found during stability testing. | Teva Pharmaceuticals USA / 25,916 cartons | Class III | Terminated |
| D-0912-2017 | 02-17-2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 48 bags | Class III | Terminated |
| D-0910-2017 | 02-17-2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 912 bags | Class III | Terminated |
| D-0907-2017 | 02-17-2017 | Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 143 bags | Class III | Terminated |
| D-0913-2017 | 02-17-2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 216 bags | Class III | Terminated |
| D-0908-2017 | 02-17-2017 | Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 144 bags | Class II | Terminated |
| D-0916-2017 | 02-17-2017 | VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 108 bags | Class II | Terminated |
| D-0500-2017 | 02-16-2017 | HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729 | cGMP deviations - presence of rubber particles found loose in the bulk product. | Allegiant Health / 70,176 bottles; 9,000,000 tablets (bulk) | Class II | Terminated |
