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 08, 2025 and include a total of 16999 recall reports.
Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
---|---|---|---|---|---|---|
D-1499-2016 | 08-03-2016 | Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90 | Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole. | Aurobindo Pharma USA Inc / 23016 bottles | Class II | Terminated |
D-1517-2016 | 08-03-2016 | Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60 | Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime. | Reckitt Benckiser LLC / 738 boxes | Class III | Terminated |
D-1472-2016 | 08-02-2016 | Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61 | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s). | Actavis Inc / 2543 bottles | Class III | Terminated |
D-1471-2016 | 08-02-2016 | Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82 | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s). | Actavis Inc / 672 bottles | Class III | Terminated |
D-1456-2016 | 08-01-2016 | Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901 | Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits. | Spectrum Laboratory Products, Inc. / 14,000 grams | Class II | Terminated |
D-1454-2016 | 08-01-2016 | Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109 | Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes. | Isomeric Pharmacy Solution, LLC / 2,331 vials | Class II | Terminated |
D-0228-2017 | 08-01-2016 | Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502 | Non-Sterility; microbial contamination identified as Bacillus circulans | Town and Country Compounding and Consultation Services / 12 vials | Class I | Terminated |
D-0024-2017 | 07-29-2016 | Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials). | CGMP Deviations | Teva Pharmaceuticals USA / 11,844 vials | Class II | Terminated |
D-0023-2017 | 07-29-2016 | Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials). | CGMP Deviations | Teva Pharmaceuticals USA / 27,547 vials | Class II | Terminated |
D-0231-2017 | 07-29-2016 | 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20. Package NDCs: 53462-705-20; 53462-705-23; 53462-705-26 | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product. | Sage Products LLC / 2756 cases | Class II | Terminated |
D-0230-2017 | 07-29-2016 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. Package NDCs: 53462-915-50; 53462-915-51; 53462-915-62; 53462-915-80; 53462-915-81; 53462-915-24; 53462-915-60; 53462-0915-62 | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product. | Sage Products LLC / 616,561 cases total | Class II | Terminated |
D-0229-2017 | 07-29-2016 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. Package NDCs: 53462-915-50; 53462-915-51; 53462-915-62; 53462-915-80; 53462-915-81; 53462-915-24; 53462-0915-62 | Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia. | Sage Products LLC / 576,802 cases total for product codes 7503, 7905, and 7526 | Class I | Terminated |
D-0209-2017 | 07-28-2016 | C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067 | Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions. | Colonia Care Pharmacy / N/A | Class II | Terminated |
D-0208-2017 | 07-28-2016 | C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067 | Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions. | Colonia Care Pharmacy / ALL | Class II | Terminated |
D-1469-2016 | 07-27-2016 | Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60. | Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point | Akorn, Inc. / 4,045 units | Class III | Terminated |
D-1535-2016 | 07-26-2016 | Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 386606 - 3 vials, 393302 - 3 vials | Class II | Terminated |
D-1541-2016 | 07-26-2016 | Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 8 bottles | Class II | Terminated |
D-1529-2016 | 07-26-2016 | Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 108 vials | Class II | Terminated |
D-1531-2016 | 07-26-2016 | Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vial | Class II | Terminated |
D-1539-2016 | 07-26-2016 | Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vial | Class II | Terminated |
D-1540-2016 | 07-26-2016 | Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 36 vials | Class II | Terminated |
D-1546-2016 | 07-26-2016 | Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / N/A | Class II | Terminated |
D-1548-2016 | 07-26-2016 | Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 23 vials | Class II | Terminated |
D-1543-2016 | 07-26-2016 | Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 6 vials | Class II | Terminated |
D-1544-2016 | 07-26-2016 | Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 139 vials | Class II | Terminated |
D-1530-2016 | 07-26-2016 | Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 5 vials | Class II | Terminated |
D-1533-2016 | 07-26-2016 | MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 6 vials | Class II | Terminated |
D-1537-2016 | 07-26-2016 | Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 14 vials | Class II | Terminated |
D-1542-2016 | 07-26-2016 | Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 6 vials | Class II | Terminated |
D-1549-2016 | 07-26-2016 | DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 6 vials | Class II | Terminated |
D-1547-2016 | 07-26-2016 | C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5.9ml solution, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 1vial | Class II | Terminated |
D-1538-2016 | 07-26-2016 | Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 16 vials | Class II | Terminated |
D-1532-2016 | 07-26-2016 | Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml, Dexamethasone Sodium Phosphate 1mg/ml, Rx only, For ophthalmic use only, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vial | Class II | Terminated |
D-1534-2016 | 07-26-2016 | Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 3 vials | Class II | Terminated |
D-1536-2016 | 07-26-2016 | Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 62 vials | Class II | Terminated |
D-1545-2016 | 07-26-2016 | C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vial | Class II | Terminated |
D-0219-2017 | 07-25-2016 | Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR | Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia | US Compounding Inc / 10,665 syringes | Class I | Terminated |
D-0105-2017 | 07-21-2016 | Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count blister packs), Distributed by Arbor Pharmaceuticals, LLC Atlanta, GA 30328, NDC 24338-700-10. | Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging. | Arbor Pharmaceuticals Inc. / 16,932 cartons | Class I | Terminated |
D-1462-2016 | 07-19-2016 | Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (h) 7500 iu with B12, (i)11,000 iu, (j)11,000 iu with B12, (k) 15,000 iu, (l) 20,000 iu, (m) 20,000 iu with B12, 10 mL sterile, depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247 | Lack of Assurance of Sterility | Talon Compounding Pharmacy / 6,500 vials | Class II | Terminated |
D-1463-2016 | 07-19-2016 | Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247 | Lack of Assurance of Sterility | Talon Compounding Pharmacy / 500 vials | Class II | Terminated |
D-1461-2016 | 07-19-2016 | Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. Package NDCs: 68382-034-06; 68382-034-16; 68382-034-10; 68382-035-06; 68382-035-16; 68382-035-10; 68382-036-06; 68382-036-16; 68382-036-10 | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Zydus Pharmaceuticals USA Inc / N/A | Class II | Terminated |
D-1460-2016 | 07-19-2016 | Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. Package NDCs: 68382-034-06; 68382-034-16; 68382-034-10; 68382-035-06; 68382-035-16; 68382-035-10; 68382-036-06; 68382-036-16; 68382-036-10 | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Zydus Pharmaceuticals USA Inc / 223,776 bottles | Class II | Terminated |
D-1442-2016 | 07-18-2016 | Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-22, | Penicillin Cross Contamination | GlaxoSmithKline, LLC / 28,131 tubes | Class II | Terminated |
D-1444-2016 | 07-18-2016 | Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11. | Penicillin Cross Contamination | GlaxoSmithKline, LLC / 153,119 tubes | Class II | Terminated |
D-1445-2016 | 07-18-2016 | Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44, | Penicillin Cross Contamination | GlaxoSmithKline, LLC / 18,000 tubes | Class II | Terminated |
D-1443-2016 | 07-18-2016 | Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25, | Penicillin Cross Contamination | GlaxoSmithKline, LLC / 7,480 tubes | Class II | Terminated |
D-0022-2017 | 07-15-2016 | Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85 | Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia | The Harvard Drug Group / 153,432 bottles | Class I | Terminated |
D-1453-2016 | 07-15-2016 | Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324; NDC 59310-206-08. | Failed Content Uniformity Specifications: out of specification test result for spray content uniformity. | Teva North America / 193,320 canisters | Class III | Terminated |
D-0112-2017 | 07-12-2016 | Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15 Package NDCs: 17772-102-70; 17772-102-01; 17772-102-30; 17772-102-15; 17772-102-10; 17772-102-12; 17772-102-07; 17772-103-70; 17772-103-01; 17772-103-30; 17772-103-15; 17772-103-10; 17772-103-12; 17772-103-07; 17772-104-70; 17772-104-01; 17772-104-30; 17772-104-15; 17772-104-12; 17772-104-10; 17772-104-07; 17772-101-70; 17772-101-01; 17772-101-30; 17772-101-15; 17772-101-10; 17772-101-12; 17772-101-07 | Superpotent Drug: Failure of assay specifications in the capsule. | Supernus Pharmaceuticals, Inc. / 17,128 (30-count blister packs) | Class II | Terminated |
D-1448-2016 | 07-11-2016 | Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09 Package NDCs: 45963-303-09; 45963-304-09; 45963-305-09 | Failed Dissolution Specifications | Actavis Inc / 8,062 units | Class II | Terminated |
D-1447-2016 | 07-07-2016 | Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94. | Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment. | Medicap Pharmacy / 1 bottle | Class II | Terminated |
D-0904-2017 | 07-07-2016 | Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205 | CGMP Deviations | Safecor Health, LLC / 856 bottles | Class II | Terminated |
D-0901-2017 | 07-07-2016 | Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009 | CGMP Deviations | Safecor Health, LLC / 119 bottles | Class II | Terminated |
D-0900-2017 | 07-07-2016 | Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280. | CGMP Deviations | Safecor Health, LLC / 66 bottles | Class II | Terminated |
D-0902-2017 | 07-07-2016 | Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392. | CGMP Deviations | Safecor Health, LLC / 25 bottles | Class II | Terminated |
D-0905-2017 | 07-07-2016 | Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402 | CGMP Deviations | Safecor Health, LLC / 1,933 bottles | Class II | Terminated |
D-0903-2017 | 07-07-2016 | Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305 | CGMP Deviations | Safecor Health, LLC / 601 bottles | Class II | Terminated |
D-1452-2016 | 07-05-2016 | Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914. | Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph. | Let's Talk Health, Inc. / 417 bottles | Class II | Terminated |
D-0107-2017 | 07-01-2016 | Dream Body 450 mg 30 capsules in a plastic screw on top bottle | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Dream Body Weight Loss / Unknown | Class II | Terminated |
D-0108-2017 | 07-01-2016 | Dream Body Advanced 400 mg 30 capsules in brown foil packets. | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Dream Body Weight Loss / Unknown | Class II | Terminated |
D-0106-2017 | 07-01-2016 | Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Dream Body Weight Loss / Unknown | Class II | Terminated |
D-1457-2016 | 06-30-2016 | Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30 | Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point. | Actavis Inc / 167,152 bottles | Class II | Terminated |
D-0099-2017 | 06-30-2016 | TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512. Package NDCs: 0023-8335-15; 0023-8335-03; 0023-8335-10; 0023-0042-03; 0023-0042-15; 0023-0042-10; 3002383350; 3002383351 | Failed Content Uniformity Specifications | Allergan Sales, LLC / 25,247 tubes (19,499 30 gram/ 5,748 100 gram) | Class II | Terminated |
D-0100-2017 | 06-30-2016 | TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159. | Failed Content Uniformity Specifications | Allergan Sales, LLC / 17,112 tubes | Class II | Terminated |
D-1166-2016 | 06-29-2016 | TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers. | Vital Care Compounder, LLC / 13 units | Class II | Terminated |
D-0169-2017 | 06-29-2016 | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01 | Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life. | Hospira Inc. / 287,200 2 mL ampules | Class III | Terminated |
D-1480-2016 | 06-29-2016 | Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, | Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles. | Isomeric Pharmacy Solution, LLC / 274 multdose vials | Class II | Terminated |
D-1255-2016 | 06-28-2016 | DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA, Martorelles, Barcelona --- NDC 60429-166-10 Package NDCs: 60429-164-60; 60429-165-30; 60429-165-90; 60429-166-30; 60429-166-10 | Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018 | Golden State Medical Supply Inc. / 2077 bottles | Class III | Terminated |
D-1446-2016 | 06-27-2016 | buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86 Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13 | Failed Dissolution Specifications | Sun Pharmaceutical Industries, Inc. / 16,085 bottles | Class III | Terminated |
D-1506-2016 | 06-27-2016 | Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 | Failed Impurities/Degradation Specifications | Sun Pharmaceutical Industries, Inc. / 612 HDPE bottles | Class III | Terminated |
D-1504-2016 | 06-27-2016 | Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 | Failed Impurities/Degradation Specifications | Sun Pharmaceutical Industries, Inc. / 4,656 HDPE bottles | Class III | Terminated |
D-1505-2016 | 06-27-2016 | Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-count bottle (NDC 57664-244-13), 1000-count bottle (NDC 57664-244-18), Rx Only, Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 | Failed Impurities/Degradation Specifications | Sun Pharmaceutical Industries, Inc. / 2,952 HDPE bottles | Class III | Terminated |
D-1507-2016 | 06-27-2016 | Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 | Failed Impurities/Degradation Specifications | Sun Pharmaceutical Industries, Inc. / 3,889 HDPE bottles | Class III | Terminated |
D-1470-2016 | 06-24-2016 | Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76 Package NDCs: 0093-2263-01; 0093-2264-01; 0093-4160-76; 0093-4160-78; 0093-4160-73; 0093-4155-79; 0093-4155-73; 0093-4155-80; 0093-4161-76; 0093-4161-78; 0093-4161-73; 0093-2267-01; 0093-2268-01; 0093-3107-01; 0093-3107-05; 0093-3109-53; 0093-3109-06; 0093-3109-01; 0093-3109-05 | Superpotent drug: Out of specification test result for assay during stability testing. | Teva North America / 53,328 bottles | Class II | Terminated |
D-1359-2016 | 06-23-2016 | Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32 Package NDCs: 0409-1273-03; 0409-1273-32 | Crystallization: Product contains particulate identified to be crystallized active ingredient. | Hospira Inc. / 373,850 tubes | Class II | Terminated |
D-1455-2016 | 06-22-2016 | Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16 | Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material. | Teva North America / 8,052 bottles | Class II | Terminated |
D-0706-2017 | 06-22-2016 | Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91 | Failed Dissolution Specifications | Mylan Pharmaceuticals Inc. / 24,176 bottles (1,450,560 tablets) | Class II | Terminated |
D-1509-2016 | 06-20-2016 | Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | W & C dba The Apothecary / 840 mL | Class II | Terminated |
D-1508-2016 | 06-20-2016 | Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | W & C dba The Apothecary / 40,000 mL | Class II | Terminated |
D-1512-2016 | 06-20-2016 | Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | W & C dba The Apothecary / 10 mL | Class II | Terminated |
D-1510-2016 | 06-20-2016 | Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | W & C dba The Apothecary / 450 mL | Class II | Terminated |
D-1511-2016 | 06-20-2016 | Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | W & C dba The Apothecary / 600 mL | Class II | Terminated |
D-1495-2016 | 06-17-2016 | Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers) | CGMP Deviations | Teva North America / 92,480 containers | Class II | Terminated |
D-1496-2016 | 06-17-2016 | Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01. | CGMP Deviations | Teva North America / 14,661 vials | Class II | Terminated |
D-1497-2016 | 06-17-2016 | Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton) | CGMP Deviations | Teva North America / 13,223 vials | Class II | Terminated |
D-1494-2016 | 06-17-2016 | ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton). | CGMP Deviations | Teva North America / 1,299 bags | Class II | Terminated |
D-1450-2016 | 06-13-2016 | Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69 | Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution. | Sagent Pharmaceuticals Inc / 3990 vials | Class II | Terminated |
D-0205-2017 | 06-13-2016 | Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14. | Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018. | Jubilant Cadista Pharmaceuticals, Inc. / 1512 bottles | Class III | Terminated |
D-1059-2016 | 06-10-2016 | SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10. | Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis. | Valeant Pharmaceuticals North America LLC / 958 Bottles | Class III | Terminated |
D-1062-2016 | 06-07-2016 | Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301, NDC 64980-0504-48 | Subpotency: product assayed and found OOS for cyproheptadine | Lyne Laboratories, Inc. / 12,215 Bottles shipped to Rising Pharmaceuticals | Class III | Terminated |
D-1063-2016 | 06-03-2016 | Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01 Package NDCs: 55111-653-30; 55111-653-01; 55111-654-30; 55111-654-01 | Failed impurities/degradation: out of specification result for impurity secorapamycin. | Dr. Reddy's Laboratories, Inc. / 9,330 bottles | Class III | Terminated |
D-1465-2016 | 06-02-2016 | Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY | Crystallization; complaints received by the manufacturer of crystals forming in product | Exact-Rx Inc / 6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz) | Class III | Terminated |
D-1061-2016 | 06-01-2016 | Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01 | Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity. | Aidarex Pharmaceuticals LLC / 599 bottles | Class III | Terminated |
D-0975-2016 | 06-01-2016 | CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01. | Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity. | Aidarex Pharmaceuticals LLC / 292 Bottles | Class II | Terminated |
D-0974-2016 | 06-01-2016 | CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01 | CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API. | Aidarex Pharmaceuticals LLC / 10 | Class III | Terminated |
D-1451-2016 | 05-31-2016 | mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01. | Failed Impurities/Degradation Specifications: High out of specification results for Impurity D. | Teva North America / 2,506 vials | Class III | Terminated |
D-1049-2016 | 05-30-2016 | Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09. | Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container. | Prinston Pharmaceutical Inc / 60 bottles (5 cases) | Class III | Terminated |
D-1038-2016 | 05-28-2016 | Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11 | Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels. | Par Pharmaceutical / 12,535 bottles | Class III | Terminated |
D-0134-2017 | 05-26-2016 | Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC | Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione. | Taro Pharmaceuticals U.S.A., Inc. / 17,100 kits | Class III | Terminated |
D-1464-2016 | 05-26-2016 | Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL. | Crystallization; Complaints that cream appears to have crystallized | Stratus Pharmaceuticals Inc / a) 12,345 tubes; b) 8,578 tubes | Class III | Completed |
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