Drug recalls
Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.
17,975 records · source: openFDA Enforcement
All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class II | August 16, 2017 | Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Single-Dose… | Lack of Sterility Assurance. | Cantrell Drug Company | Terminated |
| Class II | August 16, 2017 | HYDROMORPHONE HYDROCHLORIDE Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose… | Presence of Particulate Matter: Silicone oil | HOSPIRA INC, LAKE FOREST | Terminated |
| Class II | August 16, 2017 | HYDROMORPHONE HYDROCHLORIDE Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose… | Presence of Particulate Matter: Silicone oil | HOSPIRA INC, LAKE FOREST | Terminated |
| Class II | August 16, 2017 | HYDROMORPHONE HYDROCHLORIDE Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose… | Presence of Particulate Matter: Silicone oil | HOSPIRA INC, LAKE FOREST | Terminated |
| Class II | August 9, 2017 | Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate,… | Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. | Bayer HealthCare Pharmaceuticals, Inc. | Terminated |
| Class II | August 9, 2017 | Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg:… | Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect… | Precision Dose Inc. | Terminated |
| Class II | August 9, 2017 | Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons,… | Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of… | Apace KY LLC | Terminated |
| Class II | August 9, 2017 | Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only,… | Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of… | Apace KY LLC | Terminated |
| Class II | August 9, 2017 | 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84… | Lack of Sterility Assurance | Hospira a Pfizer Company | Terminated |
| Class II | August 9, 2017 | Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated… | Failed Tablet/Capsule Specification: out of specification for tablet weight. | PD-Rx Pharmaceuticals, Inc. | Terminated |
| Class II | August 9, 2017 | Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC,… | Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella… | Vi-Jon, Inc. | Terminated |
| Class III | August 9, 2017 | PRAVASTATIN SODIUM Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC… | Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220. | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | August 9, 2017 | Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium… | Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. | Bayer HealthCare Pharmaceuticals, Inc. | Terminated |
| Class II | August 9, 2017 | Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium… | Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. | Bayer HealthCare Pharmaceuticals, Inc. | Terminated |
| Class II | August 9, 2017 | Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC… | Lack of Sterility Assurance | Hospira a Pfizer Company | Terminated |
| Class II | August 9, 2017 | Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx… | CGMP Deviations | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical | Terminated |
| Class III | August 9, 2017 | Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x… | Failed Impurities/Degradation Specifications: high out of specification results for related compound D. | Teva Pharmaceuticals USA | Terminated |
| Class II | August 9, 2017 | Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups… | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | VistaPharm, Inc. | Terminated |
| Class II | August 9, 2017 | Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only,… | Failed Dissolution Specifications | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | August 9, 2017 | Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC… | Failed Dissolution Specifications | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | August 9, 2017 | Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC… | Failed Dissolution Specifications | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | August 9, 2017 | Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose… | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | VistaPharm, Inc. | Terminated |
| Class II | August 9, 2017 | Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL)… | Lack of Sterility Assurance | Hospira a Pfizer Company | Terminated |
| Class II | August 9, 2017 | Ibuprofen Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured… | Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen… | Time-Cap Laboratories, Inc. | Terminated |
| Class II | August 9, 2017 | Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10… | Lack of Sterility Assurance | Hospira a Pfizer Company | Terminated |
| Class II | August 9, 2017 | Famotidine Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA… | Failed Tablet/Capsule Specification; out of specification for tablet weight | Teva Pharmaceuticals USA | Terminated |
| Class II | August 2, 2017 | PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only,… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108… | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose… | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (Total… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100… | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL),… | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL… | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only,… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000… | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | August 2, 2017 | PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821… | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals | Terminated |
| Class II | July 26, 2017 | Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag… | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc | Terminated |
| Class II | July 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL… | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc | Terminated |
| Class II | July 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150 mL… | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc | Terminated |
| Class II | July 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 mL… | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc | Terminated |
| Class II | July 26, 2017 | Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL… | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc | Terminated |
| Class II | July 26, 2017 | Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia Bag, Rx… | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc | Terminated |
| Class III | July 26, 2017 | PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured… | Failed Dissolution Specifications: Low dissolution results were obtained during stability testing | Shionogi Inc. | Terminated |
| Class II | July 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 mL… | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc | Terminated |
| Class II | July 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL… | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc | Terminated |
| Class II | July 26, 2017 | Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx… | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc | Terminated |
| Class II | July 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL… | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc | Terminated |
| Class III | July 26, 2017 | Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx… | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown… | Teva Pharmaceuticals USA | Terminated |
| Class II | July 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL… | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc | Terminated |
| Class III | July 26, 2017 | Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by:… | Failed Dissolution Specifications: Low dissolution results were obtained during stability testing | Shionogi Inc. | Terminated |
| Class III | July 26, 2017 | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only,… | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown… | Teva Pharmaceuticals USA | Terminated |
| Class III | July 26, 2017 | Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed… | Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to… | Valeant Pharmaceuticals North America LLC | Terminated |
| Class II | July 26, 2017 | Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag,… | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc | Terminated |
| Class II | July 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL… | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc | Terminated |
| Class III | July 26, 2017 | Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile,… | Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during… | Hospira Inc., A Pfizer Company | Terminated |
| Class I | July 19, 2017 | ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and… | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their… | Organic Herbal Supply | Terminated |
| Class I | July 19, 2017 | ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count… | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their… | Organic Herbal Supply | Terminated |
| Class I | July 19, 2017 | RECTALIS Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4… | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their… | Organic Herbal Supply | Terminated |
| Class I | July 19, 2017 | ENHANCEROL Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count… | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their… | Organic Herbal Supply | Terminated |
| Class I | July 19, 2017 | ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsules, 500 mg,… | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their… | Organic Herbal Supply | Terminated |
| Class II | July 19, 2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag,… | Lack of Assurance of Sterility | Advanced Pharma Inc. | Terminated |
| Class II | July 19, 2017 | QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC… | Lack of Assurance of Sterility | Advanced Pharma Inc. | Terminated |
| Class I | July 19, 2017 | Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in 2, 4 and 10… | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their… | Organic Herbal Supply | Terminated |
| Class II | July 19, 2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total… | Lack of sterility assurance | SCA Pharmaceuticals | Terminated |
| Class II | July 19, 2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total… | Lack of sterility assurance | SCA Pharmaceuticals | Terminated |
| Class II | July 19, 2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag,… | Lack of Assurance of Sterility | Advanced Pharma Inc. | Terminated |
| Class I | July 19, 2017 | BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4… | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their… | Organic Herbal Supply | Terminated |
| Class I | July 19, 2017 | UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, supplied in 2, 4… | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their… | Organic Herbal Supply | Terminated |
| Class I | July 19, 2017 | LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Made… | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their… | Organic Herbal Supply | Terminated |
| Class II | July 19, 2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag,… | Lack of Assurance of Sterility | Advanced Pharma Inc. | Terminated |
| Class I | July 19, 2017 | TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied… | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their… | Organic Herbal Supply | Terminated |
| Class II | July 19, 2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total… | Lack of sterility assurance | SCA Pharmaceuticals | Terminated |
| Class II | July 19, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total… | Lack of sterility assurance | SCA Pharmaceuticals | Terminated |
| Class I | July 19, 2017 | Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, supplied in… | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their… | Organic Herbal Supply | Terminated |
| Class III | July 19, 2017 | Paroxetine Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured… | Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability… | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | July 19, 2017 | CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.3 oz (207g)… | Microbial Contamination of Non Sterile Products; out of specification Total Plate Count | Sigan Industries Inc. | Terminated |
| Class I | July 19, 2017 | Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by:… | Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which… | Teva Pharmaceuticals | Terminated |
| Class I | July 19, 2017 | EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company… | Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets… | Bristol-myers Squibb Company | Terminated |
| Class II | July 19, 2017 | SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare… | Lack of Assurance of Sterility: Bags have the potential to leak. | Baxter Healthcare Corporation | Terminated |
| Class II | July 19, 2017 | Dextrose 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare… | Lack of Assurance of Sterility: Bags have the potential to leak. | Baxter Healthcare Corporation | Terminated |
| Class I | July 19, 2017 | BRILINTA BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd.… | Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA… | AstraZeneca Pharmaceuticals, LP | Terminated |
| Class II | July 19, 2017 | SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter… | Lack of Assurance of Sterility: Customer complaints for leaking bags. | Baxter Healthcare Corporation | Terminated |
| Class II | July 12, 2017 | TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL… | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity,… | Phillips Co. | Terminated |
| Class II | July 12, 2017 | Diabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL… | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity,… | Phillips Co. | Terminated |
| Class II | July 12, 2017 | StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle,… | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity,… | Phillips Co. | Terminated |
| Class III | July 12, 2017 | Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride… | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc | Terminated |
| Class III | July 12, 2017 | Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride… | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc | Terminated |
| Class II | July 12, 2017 | VenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protectant… | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity,… | Phillips Co. | Terminated |
| Class III | July 12, 2017 | Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride… | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc | Terminated |
| Class III | July 12, 2017 | Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride… | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc | Terminated |
| Class III | July 12, 2017 | Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial,… | Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent | Lantheus MI Radipharmaceuticals Inc. | Terminated |
| Class III | July 12, 2017 | Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride… | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc | Terminated |
| Class II | July 12, 2017 | Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL in… | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity,… | Phillips Co. | Terminated |
| Class II | July 12, 2017 | Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container… | CGMP Deviations: Lack of quality assurance at the API manufacturer. | American Pharmaceutical Ingredients LLC | Terminated |
| Class II | July 12, 2017 | Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx… | Lack of Assurance of Sterility | Alvogen, Inc | Terminated |
| Class II | July 12, 2017 | StingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL)… | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity,… | Phillips Co. | Terminated |
| Class III | July 12, 2017 | Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride… | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc | Terminated |
| Class II | July 12, 2017 | Chlorhexidine Gluconate Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by:… | CGMP Deviations | Xttrium Laboratories Inc | Terminated |
| Class III | July 12, 2017 | Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride… | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc | Terminated |
| Class II | July 12, 2017 | Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB… | Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier | Fagron Compounding Services LLC dba Fagron Sterile Services | Terminated |
| Class II | July 12, 2017 | Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx… | Lack of Assurance of Sterility | Alvogen, Inc | Terminated |
| Class II | July 12, 2017 | Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx… | Lack of Assurance of Sterility | Alvogen, Inc | Terminated |
| Class III | July 12, 2017 | Clobetasol Propionate G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15),… | Failed impurities/degradation specifications: This product is being recalled due to out of specification results for… | G & W Laboratories, Inc. | Terminated |
| Class III | July 12, 2017 | Amitriptyline Hydrochloride Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01)… | Cross Contamination With Other Product: Imipramine | Sandoz Incorporated | Terminated |
| Class II | July 12, 2017 | parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis… | Presence of Foreign Substance: possibility of the presence of metal in the product. | GSK Consumer Healthcare | Terminated |
| Class III | July 5, 2017 | Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable… | Superpotent Drug: high out-of-specification result for magnesium. | Sanofi-Aventis U.S. LLC | Terminated |
| Class III | July 5, 2017 | BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by:… | Failed Moisture Limits: Product tested out-of-specification for moisture content. | Mckesson Packaging Services | Terminated |
| Class II | July 5, 2017 | Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP)… | Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities. | Allergan Sales, LLC | Terminated |
| Class III | July 5, 2017 | Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ… | Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack.… | L. Perrigo Company | Terminated |
| Class II | July 5, 2017 | Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc… | Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for… | American Pharmaceutical Ingredients LLC | Terminated |
| Class II | July 5, 2017 | Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose… | Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the… | Apothecary By Design | Terminated |
| Class III | July 5, 2017 | Minivelle Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx… | Defective Delivery System: Out of specification for peel force from the release liner specification during stability… | Noven Pharmaceuticals, Inc. | Terminated |
| Class II | June 28, 2017 | Magnesium Citrate Saline Laxative Cherry Flavored, packaged in a) 10 fl. oz. (296 mL)… | Presence of foreign substance: glass particle | Vi-Jon, Inc. | Terminated |
| Class II | June 28, 2017 | Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a) 30-count… | Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules. | Lucid Pharma LLC | Terminated |
| Class II | June 21, 2017 | NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88… | CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product… | Bausch & Lomb, Inc. | Terminated |
| Class II | June 21, 2017 | Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC.… | CGMP Deviations | Safecor Health, LLC | Terminated |
| Class II | June 21, 2017 | ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC:… | cGMP Deviations; lack of quality assurance. | American Pharmaceutical Ingredients LLC | Terminated |
| Class II | June 21, 2017 | Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk… | CGMP Deviations | Safecor Health, LLC | Terminated |
| Class II | June 21, 2017 | Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC… | CGMP Deviations | Safecor Health, LLC | Terminated |
| Class II | June 21, 2017 | VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237,… | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC | Terminated |
| Class III | June 21, 2017 | Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824,… | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC | Terminated |
| Class III | June 21, 2017 | Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc.,… | Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities | Mylan Pharmaceuticals Inc. | Terminated |
| Class II | June 21, 2017 | VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243,… | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC | Terminated |
| Class II | June 21, 2017 | Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn,… | CGMP Deviations | Safecor Health, LLC | Terminated |
| Class II | June 21, 2017 | Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC… | CGMP Deviations | Safecor Health, LLC | Terminated |
| Class III | June 21, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code… | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC | Terminated |
| Class II | June 21, 2017 | Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801,… | CGMP Deviations | Safecor Health, LLC | Terminated |
| Class I | June 21, 2017 | Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only,… | Non-sterility - presence of bacteria confirmed by outside laboratory after day 14. | Complete Pharmacy and Medical Solutions LLC | Ongoing |
| Class III | June 21, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code… | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC | Terminated |
| Class III | June 21, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code… | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC | Terminated |
| Class III | June 21, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code… | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC | Terminated |
| Class III | June 21, 2017 | Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856,… | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC | Terminated |
| Class III | June 21, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code… | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC | Terminated |
| Class II | June 21, 2017 | VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC#… | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC | Terminated |
| Class I | June 21, 2017 | Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration,… | Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture. | Complete Pharmacy and Medical Solutions LLC | Ongoing |
| Class II | June 21, 2017 | Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC#… | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC | Terminated |
| Class II | June 21, 2017 | LEVOPHED Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only,… | GMP Deviation; A foreign stopper was observed during packaging of a lot of product. | Hospira Inc., A Pfizer Company | Terminated |
| Class II | June 14, 2017 | Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and… | CGMP deviations- Lack of Quality Assurance | Qualgen | Terminated |
| Class II | June 14, 2017 | Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base,… | CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active… | Spectrum Laboratory Products, Inc. | Terminated |
| Class II | June 14, 2017 | Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count,… | CGMP deviations- Lack of Quality Assurance | Qualgen | Terminated |
| Class II | June 14, 2017 | Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count,… | CGMP deviations- Lack of Quality Assurance | Qualgen | Terminated |
| Class II | June 14, 2017 | Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count,… | CGMP deviations- Lack of Quality Assurance | Qualgen | Terminated |
| Class II | June 14, 2017 | Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx… | CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active… | Spectrum Laboratory Products, Inc. | Terminated |
| Class II | June 14, 2017 | Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and… | CGMP deviations- Lack of Quality Assurance | Qualgen | Terminated |
| Class II | June 14, 2017 | Option 2 Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box,… | Defective Container: Carton is missing the tablet blister strip and tablet. | L. Perrigo Company | Terminated |
| Class II | June 14, 2017 | Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count… | CGMP deviations- Lack of Quality Assurance | Qualgen | Terminated |
| Class II | June 14, 2017 | Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count,… | CGMP deviations- Lack of Quality Assurance | Qualgen | Terminated |
| Class II | June 14, 2017 | Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and… | CGMP deviations- Lack of Quality Assurance | Qualgen | Terminated |
| Class II | June 14, 2017 | methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy.… | Lack of Assurance of Sterility | MedPark Pharmacy, LLC | Terminated |
| Class II | June 14, 2017 | ZENATANE Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per… | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | June 14, 2017 | ZENATANE Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per… | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | June 14, 2017 | ZENATANE Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per… | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | June 14, 2017 | ZENATANE Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per… | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class III | June 14, 2017 | Acyclovir Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber… | Presence of Foreign Substance: human hair melded into tablet. | Hetero USA Inc | Terminated |
| Class II | June 7, 2017 | MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate… | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals | Terminated |
| Class II | June 7, 2017 | fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose… | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals | Terminated |
| Class II | June 7, 2017 | ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate… | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals | Terminated |
| Class II | June 7, 2017 | PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg… | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals | Terminated |
| Class II | June 7, 2017 | fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100… | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals | Terminated |
| Class II | June 7, 2017 | fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100… | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals | Terminated |
| Class II | June 7, 2017 | HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL,… | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals | Terminated |
| Class II | June 7, 2017 | ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate… | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals | Terminated |
| Class II | June 7, 2017 | morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL,… | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals | Terminated |
| Class II | June 7, 2017 | morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL,… | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals | Terminated |
| Class III | June 7, 2017 | Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles… | Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification. | VistaPharm, Inc. | Terminated |
| Class II | June 7, 2017 | SAPHRIS Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black… | Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets | Forest Laboratories, LLC | Terminated |
| Class III | June 7, 2017 | Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles,… | Subpotent Drug; Clavulanic Acid | Sandoz Inc | Terminated |
| Class II | May 31, 2017 | Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Diltiazem HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Norepinephrine Bitartrate all strengths, all dosage forms and all packaging, Rx Only,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | NOVA PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Atropine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage forms and all packaging,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Methohexital Sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Penicillin G Potassium all strengths, all dosage forms and all packaging, Rx Only, Avella… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b)… | cGMP Deviations: lack of quality assurance at the API manufacturer. | Fagron, Inc | Terminated |
| Class II | May 31, 2017 | Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class I | May 31, 2017 | Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003%… | Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated… | Standard Homeopathic Company | Terminated |
| Class II | May 31, 2017 | Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Ephedrine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Amiodarone all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Lidocaine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class III | May 31, 2017 | HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for:… | Superpotent Drug: above specification for the assay. | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals | Terminated |
| Class II | May 31, 2017 | Ropivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Nitroglycerin all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Labetalol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Potassium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Midazolam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Standard Starter TPN all strengths, all dosage forms and all packaging, Rx Only, Avella… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Magnesium Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Nalbuphine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Ondansetron HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b)… | cGMP Deviations: lack of quality assurance at the API manufacturer. | Fagron, Inc | Terminated |
| Class II | May 31, 2017 | Dexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g… | GMP Deviations; product may not meet cGMP requirements | Gentell, Inc | Terminated |
| Class II | May 31, 2017 | Rocuronium Bromide all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | 0.9% Sodium Chloride Slip Tip all strengths, all dosage forms and all packaging, Rx Only,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class I | May 31, 2017 | Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea… | Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated… | Standard Homeopathic Company | Terminated |
| Class II | May 31, 2017 | Calcium Gluconate all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Ofirmev (Acetaminophen) injection all strengths, all dosage forms and all packaging, Rx… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Sodium Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Cardioplegic Solution Maintenance all strengths, all dosage forms and all packaging, Rx… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | TPN Neonatal all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Ketamine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Adenosine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston,… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile… | Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain… | Cell Distributors | Terminated |
| Class II | May 31, 2017 | Hydromorphone HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Esmolol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Famotidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Morphine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | Epinephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |
| Class II | May 31, 2017 | ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms and all packaging, Rx… | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. | Terminated |