Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0974-2017 | 06-22-2017 | Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06 Package NDCs: 68180-647-06; 68180-647-01; 68180-647-02; 68180-647-03; 68180-646-06; 68180-646-01; 68180-646-02; 68180-646-03; 68180-645-06; 68180-645-01; 68180-645-02 | Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study. | Lupin Pharmaceuticals Inc. / 12480 bottles | Class III | Terminated |
| D-0954-2017 | 06-22-2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 72 units | Class II | Terminated |
| D-0956-2017 | 06-22-2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-922-25 | Lack of Assurance of Sterility | Advanced Pharma Inc. / | Class II | Terminated |
| D-0953-2017 | 06-22-2017 | QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. | Lack of Assurance of Sterility | Advanced Pharma Inc. / 2350 units | Class II | Terminated |
| D-0955-2017 | 06-22-2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25 | Lack of Assurance of Sterility | Advanced Pharma Inc. / | Class II | Terminated |
| D-0032-2018 | 06-22-2017 | MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; [email protected]; www.manofsteelpills.com; UPC 1 0001001378 7. | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall. | Vitility / 75 packets | Class I | Terminated |
| D-0979-2017 | 06-21-2017 | Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40 | Lack of sterility assurance | SCA Pharmaceuticals / 20 bags | Class II | Terminated |
| D-0978-2017 | 06-21-2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32 | Lack of sterility assurance | SCA Pharmaceuticals / 20 bags | Class II | Terminated |
| D-0977-2017 | 06-21-2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40 | Lack of sterility assurance | SCA Pharmaceuticals / 660 bags | Class II | Terminated |
| D-0976-2017 | 06-21-2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40 | Lack of sterility assurance | SCA Pharmaceuticals / 221 bags | Class II | Terminated |
| D-1035-2017 | 06-19-2017 | Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15 | Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg | Apace KY LLC / 1,483 cartons | Class II | Terminated |
| D-1036-2017 | 06-19-2017 | Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15 | Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg | Apace KY LLC / N/A | Class II | Terminated |
| D-0946-2017 | 06-19-2017 | Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405 | Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier | Fagron Compounding Services LLC dba Fagron Sterile Services / 1,056 5mL syringes | Class II | Terminated |
| D-0939-2017 | 06-16-2017 | Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-462-69 | Lack of Assurance of Sterility | Alvogen, Inc / 5,100 2 mL vials | Class II | Terminated |
| D-0940-2017 | 06-16-2017 | Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69 | Lack of Assurance of Sterility | Alvogen, Inc / 72,575 4 mL vials | Class II | Terminated |
| D-0941-2017 | 06-16-2017 | Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69 | Lack of Assurance of Sterility | Alvogen, Inc / 71,825 6 mL vials | Class II | Terminated |
| D-0943-2017 | 06-16-2017 | Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540 Package NDCs: 0781-1486-10; 0781-1486-01; 0781-1486-31; 0781-1487-10; 0781-1487-01; 0781-1487-31; 0781-1488-10; 0781-1488-01; 0781-1488-31; 0781-1489-31; 0781-1489-01; 0781-1489-10; 0781-1490-10; 0781-1490-01; 0781-1490-31; 0781-1491-10; 0781-1491-01; 0781-1491-31 | Cross Contamination With Other Product: Imipramine | Sandoz Incorporated / 38,234 bottles | Class III | Terminated |
| D-1055-2017 | 06-16-2017 | Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50 Package NDCs: 49483-602-01; 49483-602-50; 49483-603-03; 49483-603-50; 49483-603-05; 49483-603-01; 49483-604-01; 49483-604-50; 49483-604-05; 49483-604-03 | Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg. | Time-Cap Laboratories, Inc. / 1,980 bottles | Class II | Terminated |
| D-1048-2017 | 06-15-2017 | Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25). Package NDCs: 0409-6629-12; 0409-6629-02; 0409-6970-10; 0409-6629-25 | Lack of Sterility Assurance | Hospira a Pfizer Company / 15,034,600 10 mL multiple dose use vials | Class II | Terminated |
| D-1126-2017 | 06-15-2017 | Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01 Package NDCs: 27808-084-01; 27808-084-02; 27808-082-01; 27808-082-02 | Defective container: Oral solution leaking from container. | Tris Pharma Inc. / 34,824 bottles | Class II | Terminated |
| D-1046-2017 | 06-15-2017 | Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01 | Lack of Sterility Assurance | Hospira a Pfizer Company / 20,337,650 15 mL single dose vials | Class II | Terminated |
| D-1047-2017 | 06-15-2017 | 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02 | Lack of Sterility Assurance | Hospira a Pfizer Company / 91,483,150 50 mL single dose vials | Class II | Terminated |
| D-1049-2017 | 06-15-2017 | Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA | Lack of Sterility Assurance | Hospira a Pfizer Company / 21,436,700 5mL single dose vials | Class II | Terminated |
| D-0975-2017 | 06-13-2017 | CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.3 oz (207g) tubes, OTC, Distributed by CVS Pharmacy Inc., Woonsocket, RI --- UPC 050428568033 | Microbial Contamination of Non Sterile Products; out of specification Total Plate Count | Sigan Industries Inc. / 19,608 tubes | Class II | Terminated |
| D-0922-2017 | 06-12-2017 | Magnesium Citrate Saline Laxative Cherry Flavored, packaged in a) 10 fl. oz. (296 mL) bottle UPC: 072785104556 (Rexall's label), b) 10 fl. oz. (296 mL) bottle UPC: 041163254138 (Equaline's label), OTC, Distributed by a) Dolgencorp, LL, Goodlettsville, TN 37072 b)Supervalu, Inc. Eden Prairie, MN 55344 | Presence of foreign substance: glass particle | Vi-Jon, Inc. / 52,212 bottles | Class II | Terminated |
| D-0926-2017 | 06-12-2017 | Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8. | Superpotent Drug: high out-of-specification result for magnesium. | Sanofi-Aventis U.S. LLC / 2980 bottles | Class III | Terminated |
| D-0119-2018 | 06-09-2017 | NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61. | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. | Advanced Pharma Inc. / 550 syringes | Class II | Terminated |
| D-0117-2018 | 06-09-2017 | NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62. | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. | Advanced Pharma Inc. / 50 syringes | Class II | Terminated |
| D-0116-2018 | 06-09-2017 | NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61. | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. | Advanced Pharma Inc. / 4800 syringes | Class II | Terminated |
| D-0113-2018 | 06-09-2017 | NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61. | Subpotent Drug: found to be below the specification for labeled assay. | Advanced Pharma Inc. / 550 syringes | Class I | Terminated |
| D-0114-2018 | 06-09-2017 | NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67. | Subpotent Drug: found to be below the specification for labeled assay. | Advanced Pharma Inc. / 320 syringes | Class I | Terminated |
| D-0118-2018 | 06-09-2017 | NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67. | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. | Advanced Pharma Inc. / 680 syringes | Class II | Terminated |
| D-0115-2018 | 06-09-2017 | NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61. | Subpotent Drug: found to be below the specification for labeled assay. | Advanced Pharma Inc. / 50 syringes | Class I | Terminated |
| D-0948-2017 | 06-08-2017 | TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-301-11 | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. | Phillips Co. / 200-300 bottles | Class II | Terminated |
| D-0949-2017 | 06-08-2017 | Diabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-100-11 | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. | Phillips Co. / 100-200 bottles | Class II | Terminated |
| D-0951-2017 | 06-08-2017 | StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 43074-101-01 | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. | Phillips Co. / 10-30 bottles/units | Class II | Terminated |
| D-0947-2017 | 06-08-2017 | Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 4307410201 | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. | Phillips Co. / 100-200 bottles | Class II | Terminated |
| D-0952-2017 | 06-08-2017 | VenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protectant Phillips Company, Millerton, OK -- NDC 43074-207-01 | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. | Phillips Co. / 20-50 bottles/units | Class II | Terminated |
| D-0950-2017 | 06-08-2017 | StingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 04307-100-11 | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. | Phillips Co. / 20-50 bottles/units | Class II | Terminated |
| D-0899-2017 | 06-06-2017 | NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distributed by: Medtech Products, Inc., Tarrytown, NY 10591, UPC 8 148332 01101 7. | CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot. | Bausch & Lomb, Inc. / 44,520 bottles | Class II | Terminated |
| D-1142-2017 | 06-06-2017 | ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one azine 10 mg) capsule, packaged in 60-count bottle, Andropharm.com, UPC: 6 42125 50294 8 | Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. | Andropharm, LLC / 150 bottles | Class I | Terminated |
| D-1143-2017 | 06-06-2017 | ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4 | Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. | Andropharm, LLC / 1250 bottles | Class I | Terminated |
| D-0925-2017 | 06-05-2017 | Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by one paper sleeve, TOTAL 24 FL OZ (1.5 pt)(710 mL), OTC, Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015 | Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid. | L. Perrigo Company / 1,998 combo packs | Class III | Terminated |
| D-0924-2017 | 06-05-2017 | Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME. | Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure. | Apothecary By Design / 25 vials | Class II | Terminated |
| D-0959-2017 | 06-05-2017 | EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA and Pfizer Inc. New York, NY 10017 USA, NDC 0003-0894-21 | Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets. | Bristol-myers Squibb Company / 48,180 bottles | Class I | Terminated |
| D-0945-2017 | 06-02-2017 | G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080 Package NDCs: 0713-0656-15; 0713-0656-31; 0713-0656-37; 0713-0656-60 | Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product. | G & W Laboratories, Inc. / 145284 tubes | Class III | Terminated |
| D-0888-2017 | 06-01-2017 | methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401 | Lack of Assurance of Sterility | MedPark Pharmacy, LLC / 1 (5mL) vial | Class II | Terminated |
| D-0927-2017 | 06-01-2017 | Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon container (NDC: 58597-8082-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient. | American Pharmaceutical Ingredients LLC / 23.5kg | Class II | Terminated |
| D-0938-2017 | 06-01-2017 | Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16 Package NDCs: 0116-2001-16; 0116-2001-04; 0116-2001-15; 0116-2001-05; 0116-2001-06; 0116-2001-07 | CGMP Deviations | Xttrium Laboratories Inc / 36,720 16 oz. glass bottles | Class II | Terminated |
| D-0887-2017 | 06-01-2017 | Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box, Distributed By Perrigo, Allegan, MI 49010. NDC 0113-2003-12 Package NDCs: 0113-2003-12 | Defective Container: Carton is missing the tablet blister strip and tablet. | L. Perrigo Company / 181,776 (units/eaches) | Class II | Terminated |
| D-0921-2017 | 06-01-2017 | Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a) 30-count bottles (NDC 52343-132-30) and b) 90-count bottles (NDC 52343-132-90), Rx only, Distributed by: Lucid Pharma LLC, 2 Tower Center Blvd, Suite-1101-B, East Brunswick, NJ 08816 USA. | Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules. | Lucid Pharma LLC / a) 44168 bottles; b) 24960 bottles | Class II | Terminated |
| D-0960-2017 | 05-31-2017 | Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19 | Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification. | Teva Pharmaceuticals / 360 bottles | Class I | Terminated |
| D-0928-2017 | 05-30-2017 | BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10 | Failed Moisture Limits: Product tested out-of-specification for moisture content. | Mckesson Packaging Services / 942 cartons | Class III | Terminated |
| D-0937-2017 | 05-26-2017 | Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of quality assurance at the API manufacturer. | American Pharmaceutical Ingredients LLC / 5,000g (5 kg) | Class II | Terminated |
| D-0958-2017 | 05-25-2017 | BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850; By: AstraZeneca AB, SE-151 85 Sodertalje, Sweden, NDC 0186-0777-08. Package NDCs: 0186-0777-08; 0186-0777-60; 0186-0777-18; 0186-0777-39; 0186-0777-28; 0186-0776-60; 0186-0776-94 | Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets. | AstraZeneca Pharmaceuticals, LP / 40,368 bottles | Class I | Terminated |
| D-1117-2017 | 05-25-2017 | CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987 | Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk | Brian P. Richardson / Unknown | Class I | Terminated |
| D-0982-2017 | 05-24-2017 | PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981 | Failed Dissolution Specifications: Low dissolution results were obtained during stability testing | Shionogi Inc. / 455 bottles | Class III | Terminated |
| D-0219-2018 | 05-24-2017 | Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30 | Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules | Shionogi Inc. / 968 bottles | Class III | Terminated |
| D-0981-2017 | 05-24-2017 | Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30 | Failed Dissolution Specifications: Low dissolution results were obtained during stability testing | Shionogi Inc. / 6304 bottles | Class III | Terminated |
| D-0886-2017 | 05-22-2017 | Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-137-81 Package NDCs: 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78 | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Dr. Reddy's Laboratories, Inc. / 452,290 cartons | Class II | Terminated |
| D-0884-2017 | 05-22-2017 | Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81 Package NDCs: 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78 | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Dr. Reddy's Laboratories, Inc. / 89,118 cartons | Class II | Terminated |
| D-0885-2017 | 05-22-2017 | Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-113-81 Package NDCs: 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78 | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Dr. Reddy's Laboratories, Inc. / 223,650 cartons | Class II | Terminated |
| D-0883-2017 | 05-22-2017 | Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81 Package NDCs: 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78 | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Dr. Reddy's Laboratories, Inc. / 13,221 cartons | Class II | Terminated |
| D-1096-2017 | 05-22-2017 | Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine Nutrients Corp, 1801 S. Canal St, Chicago, IL 60616, UPC 021754905076 | Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use. | Global Marketing Enterprises, Inc. / 52.5 kg | Class II | Terminated |
| D-1087-2017 | 05-19-2017 | Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy 9 Suite 600-441 Alpharetta, GA 30004 | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine. | DYNAMIC TECHNICAL FORMULATIONS / 728 bottles | Class I | Terminated |
| D-0874-2017 | 05-18-2017 | fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 100 bags | Class II | Terminated |
| D-0878-2017 | 05-18-2017 | MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 40 bags | Class II | Terminated |
| D-0877-2017 | 05-18-2017 | ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 70 bags | Class II | Terminated |
| D-0872-2017 | 05-18-2017 | fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 118 bags | Class II | Terminated |
| D-0879-2017 | 05-18-2017 | PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 30 bags | Class II | Terminated |
| D-0873-2017 | 05-18-2017 | fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 370 bags | Class II | Terminated |
| D-0875-2017 | 05-18-2017 | HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 87 bags | Class II | Terminated |
| D-0876-2017 | 05-18-2017 | ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 240 bags | Class II | Terminated |
| D-0870-2017 | 05-18-2017 | morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32. | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 80 bags | Class II | Terminated |
| D-0871-2017 | 05-18-2017 | morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-55 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 56 bags | Class II | Terminated |
| D-0898-2017 | 05-18-2017 | Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04 Package NDCs: 0409-3375-14; 0409-3375-04; 0409-1443-14; 0409-1443-04 | GMP Deviation; A foreign stopper was observed during packaging of a lot of product. | Hospira Inc., A Pfizer Company / (720503A): 43,200 vials, (720603A): 400 vials | Class II | Terminated |
| D-0880-2017 | 05-18-2017 | Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmaceuticals, Inc. subsidiary of Forest Laboratories, LLC, Cincinnati OH 45209 USA --- NDC 0456-2410-60; Shellpack containing 1 blister card --- NDC 0456-2410-06 Package NDCs: 0456-2402-10; 0456-2402-06; 0456-2402-60; 0456-2402-11; 0456-2402-63; 0456-2405-10; 0456-2405-06; 0456-2405-60; 0456-2405-11; 0456-2405-63; 0456-2410-10; 0456-2410-06; 0456-2410-60; 0456-2410-11; 0456-2410-63 | Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets | Forest Laboratories, LLC / 40,621 blister packs | Class II | Terminated |
| D-0942-2017 | 05-18-2017 | Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01 | Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent | Lantheus MI Radipharmaceuticals Inc. / 26 doses | Class III | Terminated |
| D-1059-2017 | 05-17-2017 | Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61 | Presence of Foreign Substance: potential presence of plastic particles. | X-Gen Pharmaceuticals Inc. / 9,816 bottles | Class II | Terminated |
| D-0869-2017 | 05-17-2017 | Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771. | Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification. | VistaPharm, Inc. / 2,208,500 cups/18696 bottles | Class III | Terminated |
| D-0793-2017 | 05-16-2017 | Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20. Package NDCs: 0173-0682-20; 0173-0682-24 | Defective Delivery System: Elevated number of units with out of specification results for leak rate | GlaxoSmithKline, LLC / 562,883 | Class II | Ongoing |
| D-1093-2017 | 05-16-2017 | Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 | Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package. | Lupin Limited (Unit 1) / 24,652 tablets | Class I | Terminated |
| D-0788-2017 | 05-15-2017 | Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48 Package NDCs: 0338-6046-48; 0338-6045-37 | Lack of assurance of sterility: customer complaints received for the presence of leaks. | Baxter Healthcare Corporation / 113,590 bags | Class II | Terminated |
| D-0789-2017 | 05-15-2017 | Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48 Package NDCs: 0338-6010-48; 0338-6011-37 | Lack of assurance of sterility: customer complaints received for the presence of leaks. | Baxter Healthcare Corporation / 90,450 bags | Class II | Terminated |
| D-1060-2017 | 05-11-2017 | Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485. | GMP Deviations: The firm does not include an SOP for testing for out of specifications. | AtHome Medical, Inc. / 80 lbs | Class II | Terminated |
| D-1041-2017 | 05-10-2017 | Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01 | Failed Dissolution Specifications | Zydus Pharmaceuticals USA Inc / 108,096 HDPE bottles | Class II | Terminated |
| D-1042-2017 | 05-10-2017 | Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054 | Failed Dissolution Specifications | Zydus Pharmaceuticals USA Inc / 115,122 HDPE bottles | Class II | Terminated |
| D-1043-2017 | 05-10-2017 | Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054 | Failed Dissolution Specifications | Zydus Pharmaceuticals USA Inc / 108,726 HDPE bottles | Class II | Terminated |
| D-0858-2017 | 05-09-2017 | Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06 Package NDCs: 64380-712-06; 64380-712-07; 64380-713-06; 64380-713-07 | Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content. | Strides Pharma INC / 127,517 bottles | Class III | Terminated |
| D-0920-2017 | 05-09-2017 | Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93 | Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities | Mylan Pharmaceuticals Inc. / 11,624 pouches | Class III | Terminated |
| D-0859-2017 | 05-08-2017 | HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52. | Superpotent Drug: above specification for the assay. | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals / 109,620 bottles | Class III | Terminated |
| D-1134-2017 | 05-05-2017 | AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10 Package NDCs: 67877-197-90; 67877-197-05; 67877-197-10; 67877-197-38; 67877-198-90; 67877-198-05; 67877-198-10; 67877-198-38; 67877-199-90; 67877-199-05; 67877-199-10; 67877-199-38 | PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg. | Ascend Laboratories LLC / 1212 bottles | Class III | Terminated |
| D-1092-2017 | 05-05-2017 | GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842 | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances. | Genetic Edge Compounds LLC / 1759 bottles ( 105, 540 capsules) | Class I | Terminated |
| D-1127-2017 | 05-02-2017 | Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01 Package NDCs: 68180-150-01 | CGMP Deviations | Lupin Pharmaceuticals Inc. / 12,888 bottles | Class III | Terminated |
| D-0929-2017 | 05-01-2017 | Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04. | Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities. | Allergan Sales, LLC / 648 units | Class II | Terminated |
| D-0698-2017 | 04-28-2017 | Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977. Package NDCs: 42023-179-05; 42023-179-01 | Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component. | PAR Sterile Products LLC / 122,469 cartons | Class II | Terminated |
| D-0897-2017 | 04-27-2017 | Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01 Package NDCs: 31722-777-01; 31722-777-05; 31722-778-01; 31722-778-05 | Presence of Foreign Substance: human hair melded into tablet. | Hetero USA Inc / 13,692 bottles | Class III | Terminated |
| D-0923-2017 | 04-27-2017 | Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8 Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8 | Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH. | Noven Pharmaceuticals, Inc. / 14434 cartons | Class III | Terminated |
| D-0868-2017 | 04-26-2017 | Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20 Package NDCs: 0781-1874-31; 0781-1831-20; 0781-1831-13; 0781-1831-01; 0781-1852-20; 0781-1852-13; 0781-1852-01; 0781-6102-46; 0781-6102-57; 0781-6102-52; 0781-6104-46; 0781-6104-57; 0781-6104-52 | Subpotent Drug; Clavulanic Acid | Sandoz Inc / 4,464 bottles | Class III | Terminated |
| D-0705-2017 | 04-24-2017 | Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel | Microbial Contamination of Non-Sterile Products | Teva Pharmaceuticals USA / N/A | Class II | Terminated |
