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-1499-201608-03-2016Pantoprazole 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 65862-0560-90Presence 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 bottlesClass IITerminated
D-1517-201608-03-2016Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60Labeling: 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 boxesClass IIITerminated
D-1472-201608-02-2016Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61Failed 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 bottlesClass IIITerminated
D-1471-201608-02-2016Acetasol 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 0472-0882-82Failed 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 bottlesClass IIITerminated
D-1456-201608-01-2016Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.Spectrum Laboratory Products, Inc. / 14,000 gramsClass IITerminated
D-1454-201608-01-2016Betamethasone 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 84109Lack 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 vialsClass IITerminated
D-0228-201708-01-2016Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502Non-Sterility; microbial contamination identified as Bacillus circulansTown and Country Compounding and Consultation Services / 12 vialsClass ITerminated
D-0024-201707-29-2016Amikacin 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 DeviationsTeva Pharmaceuticals USA / 11,844 vialsClass IITerminated
D-0023-201707-29-2016Amikacin 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 DeviationsTeva Pharmaceuticals USA / 27,547 vialsClass IITerminated
D-0231-201707-29-20162% 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 casesClass IITerminated
D-0230-201707-29-2016COMFORT 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 totalClass IITerminated
D-0229-201707-29-2016COMFORT 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 7526Class ITerminated
D-0209-201707-28-2016C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.Colonia Care Pharmacy / N/AClass IITerminated
D-0208-201707-28-2016C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.Colonia Care Pharmacy / ALLClass IITerminated
D-1469-201607-27-2016Desoximetasone 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 pointAkorn, Inc. / 4,045 unitsClass IIITerminated
D-1535-201607-26-2016Papaverine 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 39402Lack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 386606 - 3 vials, 393302 - 3 vialsClass IITerminated
D-1541-201607-26-2016Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402Lack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 8 bottlesClass IITerminated
D-1529-201607-26-2016Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402Lack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 108 vialsClass IITerminated
D-1531-201607-26-2016Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MSLack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 1 vialClass IITerminated
D-1539-201607-26-2016Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MSLack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 1 vialClass IITerminated
D-1540-201607-26-2016Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402Lack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 36 vialsClass IITerminated
D-1546-201607-26-2016Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MSLack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / N/AClass IITerminated
D-1548-201607-26-2016Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402Lack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 23 vialsClass IITerminated
D-1543-201607-26-2016Pre-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, MSLack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 6 vialsClass IITerminated
D-1544-201607-26-2016Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MSLack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 139 vialsClass IITerminated
D-1530-201607-26-2016Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compounder, Hattiesburg, MSLack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 5 vialsClass IITerminated
D-1533-201607-26-2016MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402Lack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 6 vialsClass IITerminated
D-1537-201607-26-2016Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402Lack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 14 vialsClass IITerminated
D-1542-201607-26-2016Pre-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, MSLack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 6 vialsClass IITerminated
D-1549-201607-26-2016DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MSLack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 6 vialsClass IITerminated
D-1547-201607-26-2016C-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, MSLack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 1vialClass IITerminated
D-1538-201607-26-2016Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402Lack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 16 vialsClass IITerminated
D-1532-201607-26-2016Moxifloxacin 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, MSLack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 1 vialClass IITerminated
D-1534-201607-26-2016Papaverine 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 39402Lack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 3 vialsClass IITerminated
D-1536-201607-26-2016Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402Lack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 62 vialsClass IITerminated
D-1545-201607-26-2016C-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 39402Lack of Assurance of SterilityPharmacy Plus, Inc. dba Vital Care Compounder / 1 vialClass IITerminated
D-0219-201707-25-2016Docusate 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, ARMicrobial Contamination of Non-Sterile Products; microbial contamination with B. cepaciaUS Compounding Inc / 10,665 syringesClass ITerminated
D-0105-201707-21-2016Cetylev (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 cartonsClass ITerminated
D-1462-201607-19-2016Human 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 78247Lack of Assurance of SterilityTalon Compounding Pharmacy / 6,500 vialsClass IITerminated
D-1463-201607-19-2016Sermorelin 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 78247Lack of Assurance of SterilityTalon Compounding Pharmacy / 500 vialsClass IITerminated
D-1461-201607-19-2016Venlafaxine 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 samplesZydus Pharmaceuticals USA Inc / N/AClass IITerminated
D-1460-201607-19-2016Venlafaxine 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 samplesZydus Pharmaceuticals USA Inc / 223,776 bottlesClass IITerminated
D-1442-201607-18-2016Bactroban 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 ContaminationGlaxoSmithKline, LLC / 28,131 tubesClass IITerminated
D-1444-201607-18-2016Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11.Penicillin Cross ContaminationGlaxoSmithKline, LLC / 153,119 tubesClass IITerminated
D-1445-201607-18-2016Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,Penicillin Cross ContaminationGlaxoSmithKline, LLC / 18,000 tubesClass IITerminated
D-1443-201607-18-2016Bactroban 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 ContaminationGlaxoSmithKline, LLC / 7,480 tubesClass IITerminated
D-0022-201707-15-2016Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepaciaThe Harvard Drug Group / 153,432 bottlesClass ITerminated
D-1453-201607-15-2016Children'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 canistersClass IIITerminated
D-0112-201707-12-2016Trokendi 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 IITerminated
D-1448-201607-11-2016Dextroamphetamine 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 SpecificationsActavis Inc / 8,062 unitsClass IITerminated
D-1447-201607-07-2016Acetylcyst 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 bottleClass IITerminated
D-0904-201707-07-2016Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205CGMP DeviationsSafecor Health, LLC / 856 bottlesClass IITerminated
D-0901-201707-07-2016Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009CGMP DeviationsSafecor Health, LLC / 119 bottlesClass IITerminated
D-0900-201707-07-2016Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.CGMP DeviationsSafecor Health, LLC / 66 bottlesClass IITerminated
D-0902-201707-07-2016Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.CGMP DeviationsSafecor Health, LLC / 25 bottlesClass IITerminated
D-0905-201707-07-2016Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402CGMP DeviationsSafecor Health, LLC / 1,933 bottlesClass IITerminated
D-0903-201707-07-2016Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305CGMP DeviationsSafecor Health, LLC / 601 bottlesClass IITerminated
D-1452-201607-05-2016Oxygen 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 bottlesClass IITerminated
D-0107-201707-01-2016Dream Body 450 mg 30 capsules in a plastic screw on top bottleMarketed without an approved NDA/ANDA: Undeclared sibutramine.Dream Body Weight Loss / UnknownClass IITerminated
D-0108-201707-01-2016Dream Body Advanced 400 mg 30 capsules in brown foil packets.Marketed without an approved NDA/ANDA: Undeclared sibutramine.Dream Body Weight Loss / UnknownClass IITerminated
D-0106-201707-01-2016Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottleMarketed without an approved NDA/ANDA: Undeclared sibutramine.Dream Body Weight Loss / UnknownClass IITerminated
D-1457-201606-30-2016Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.Actavis Inc / 167,152 bottlesClass IITerminated
D-0099-201706-30-2016TAZORAC (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 SpecificationsAllergan Sales, LLC / 25,247 tubes (19,499 30 gram/ 5,748 100 gram)Class IITerminated
D-0100-201706-30-2016TAZORAC (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 SpecificationsAllergan Sales, LLC / 17,112 tubesClass IITerminated
D-1166-201606-29-2016TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MSLack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers.Vital Care Compounder, LLC / 13 unitsClass IITerminated
D-0169-201706-29-20165% 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 0409-4712-01Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.Hospira Inc. / 287,200 2 mL ampulesClass IIITerminated
D-1480-201606-29-2016Methylprednisolone 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 vialsClass IITerminated
D-1255-201606-28-2016DULOXETINE 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 02/2018Golden State Medical Supply Inc. / 2077 bottlesClass IIITerminated
D-1446-201606-27-2016buPROPion 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 SpecificationsSun Pharmaceutical Industries, Inc. / 16,085 bottlesClass IIITerminated
D-1506-201606-27-2016Carvediol 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 08512Failed Impurities/Degradation SpecificationsSun Pharmaceutical Industries, Inc. / 612 HDPE bottlesClass IIITerminated
D-1504-201606-27-2016Carvediol 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 08512Failed Impurities/Degradation SpecificationsSun Pharmaceutical Industries, Inc. / 4,656 HDPE bottlesClass IIITerminated
D-1505-201606-27-2016Carvediol 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 08512Failed Impurities/Degradation SpecificationsSun Pharmaceutical Industries, Inc. / 2,952 HDPE bottlesClass IIITerminated
D-1507-201606-27-2016Carvediol 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 08512Failed Impurities/Degradation SpecificationsSun Pharmaceutical Industries, Inc. / 3,889 HDPE bottlesClass IIITerminated
D-1470-201606-24-2016Amoxicillin 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 bottlesClass IITerminated
D-1359-201606-23-2016Diazepam 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 tubesClass IITerminated
D-1455-201606-22-2016Albuterol 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 0093-0661-16Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.Teva North America / 8,052 bottlesClass IITerminated
D-0706-201706-22-2016Alprazolam 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 0378-5022-91Failed Dissolution SpecificationsMylan Pharmaceuticals Inc. / 24,176 bottles (1,450,560 tablets)Class IITerminated
D-1509-201606-20-2016Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377Lack 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 mLClass IITerminated
D-1508-201606-20-2016Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377Lack 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 mLClass IITerminated
D-1512-201606-20-2016Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377Lack 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 mLClass IITerminated
D-1510-201606-20-2016Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377Lack 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 mLClass IITerminated
D-1511-201606-20-2016Papaverine 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 56377Lack 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 mLClass IITerminated
D-1495-201606-17-2016Linezolid 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 DeviationsTeva North America / 92,480 containersClass IITerminated
D-1496-201606-17-2016Eptifibatide 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 DeviationsTeva North America / 14,661 vialsClass IITerminated
D-1497-201606-17-2016Ondansetron 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 DeviationsTeva North America / 13,223 vialsClass IITerminated
D-1494-201606-17-2016ARGATROBAN 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 DeviationsTeva North America / 1,299 bagsClass IITerminated
D-1450-201606-13-2016Oxacillin 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 25021-163-69Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.Sagent Pharmaceuticals Inc / 3990 vialsClass IITerminated
D-0205-201706-13-2016Methylprednisolone 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 bottlesClass IIITerminated
D-1059-201606-10-2016SECONAL 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 BottlesClass IIITerminated
D-1062-201606-07-2016Cyproheptadine 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 64980-0504-48Subpotency: product assayed and found OOS for cyproheptadineLyne Laboratories, Inc. / 12,215 Bottles shipped to Rising PharmaceuticalsClass IIITerminated
D-1063-201606-03-2016Sirolimus 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 bottlesClass IIITerminated
D-1465-201606-02-2016Urea (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, NYCrystallization; complaints received by the manufacturer of crystals forming in productExact-Rx Inc / 6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)Class IIITerminated
D-1061-201606-01-2016Ciprofloxacin 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) 33261-0614-01Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.Aidarex Pharmaceuticals LLC / 599 bottlesClass IIITerminated
D-0975-201606-01-2016CHLORHEXIDINE 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 BottlesClass IITerminated
D-0974-201606-01-2016CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.Aidarex Pharmaceuticals LLC / 10Class IIITerminated
D-1451-201605-31-2016mitoXANTRONE 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 vialsClass IIITerminated
D-1049-201605-30-2016Irbesartan 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 IIITerminated
D-1038-201605-28-2016Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11Failed 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 bottlesClass IIITerminated
D-0134-201705-26-2016Kamedis 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. NDCSubpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.Taro Pharmaceuticals U.S.A., Inc. / 17,100 kitsClass IIITerminated
D-1464-201605-26-2016Remeven 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 crystallizedStratus Pharmaceuticals Inc / a) 12,345 tubes; b) 8,578 tubesClass IIICompleted