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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0914-2018 | 02-26-2018 | RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10 | Failed Stability Specifications | Mckesson Packaging Services / 17,192 cartons (1,719,200 tablets) | Class II | Terminated |
| D-0585-2018 | 02-23-2018 | Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by: Patheon Pharmaceuticals, Inc. Cincinnati OH 45237 Product of Switzerland NDC 0310-0657-58 | Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph). | AstraZeneca Pharmaceuticals LP / 18056 bottles | Class III | Terminated |
| D-0590-2018 | 02-23-2018 | Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636. | Labeling: Label mix-up | Bayer HealthCare Pharmaceuticals, Inc. / 528 units | Class II | Terminated |
| D-0603-2018 | 02-22-2018 | labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028 | Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018 | SCA Pharmaceuticals, LLC. / 480 syringes | Class III | Terminated |
| D-0696-2018 | 02-21-2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10 | Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags. | Renaissance Lakewood, LLC / 1784 bags | Class II | Terminated |
| D-0577-2018 | 02-21-2018 | Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05 | Failed Stability Specification: OOS low viscosity results discovered during retain testing. | Akorn, Inc. / 31,812 bottles | Class III | Terminated |
| D-0576-2018 | 02-20-2018 | Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25. | Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal. | Hospira Inc. A Pfizer Company / a) 137,975 vials; b) 40,143 vials | Class II | Terminated |
| D-0582-2018 | 02-19-2018 | Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05 | cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | Kalchem International, Inc. / 500 gram jar | Class II | Terminated |
| D-0549-2018 | 02-16-2018 | 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00. Package NDCs: 0264-2201-00; 0264-2201-10; 0264-2201-50; 0264-2201-70 | Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received. | B. Braun Medical Inc / 17,360 plastic irrigation containers | Class II | Terminated |
| D-0546-2018 | 02-15-2018 | PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04 Package NDCs: 53329-938-06; 53329-938-08; 53329-938-23; 53329-938-25; 53329-938-04 | Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. | Medline Industries Inc / 67,104 bottles | Class II | Terminated |
| D-0579-2018 | 02-15-2018 | Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25. | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. | Apollo Care / 360 bags | Class II | Terminated |
| D-0580-2018 | 02-15-2018 | Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-264-25. | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. | Apollo Care / 312 bags | Class II | Terminated |
| D-0593-2018 | 02-14-2018 | Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015 | Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall. | Bella All Natural / 32 bottles | Class I | Terminated |
| D-0547-2018 | 02-14-2018 | SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120 | Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus). | Fagron, Inc / a) 1007 bottles (500 mL) and b) 738 bottles (4 L) | Class II | Terminated |
| D-0550-2018 | 02-14-2018 | Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01 Package NDCs: 54482-020-01; 54482-020-02; 54482-035-02 | Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride. | LEADIANT BIOSCIENCES, INC / 1,705 bottles | Class III | Terminated |
| D-0601-2018 | 02-13-2018 | Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60 Package NDCs: 31722-832-60; 31722-832-31; 31722-832-32 | Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018). | Hetero Labs Limited Unit V / 1764 60-count bottles | Class II | Terminated |
| D-0473-2018 | 02-13-2018 | Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02 | Presence of Foreign Tablets/Capsules | Nostrum Laboratories Inc / 1,439,000 oral capsules | Class III | Terminated |
| D-0602-2018 | 02-13-2018 | Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India NDC # 31722-705-30 Package NDCs: 31722-704-30; 31722-704-60; 31722-704-90; 31722-704-01; 31722-704-05; 31722-704-31; 31722-704-32; 31722-705-30; 31722-705-60; 31722-705-90; 31722-705-01; 31722-705-05 | Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018). | Hetero Labs Limited Unit V / 48132 60-count bottles | Class II | Terminated |
| D-0544-2018 | 02-09-2018 | Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478 Package NDCs: 50268-061-11; 50268-061-15; 50268-062-11; 50268-062-15 | Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities. | Apace KY LLC / 630 cartons | Class II | Terminated |
| D-0539-2018 | 02-09-2018 | Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / N/A | Class II | Terminated |
| D-0475-2018 | 02-09-2018 | Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327. | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 684 g | Class II | Terminated |
| D-0522-2018 | 02-09-2018 | Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 10000 g | Class II | Terminated |
| D-0479-2018 | 02-09-2018 | Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 1300 g | Class II | Terminated |
| D-0535-2018 | 02-09-2018 | Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) 5000g (NDC 58597-8120-9); e) 25000g (NDC 58597-8120-3), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 200000 g | Class II | Terminated |
| D-0503-2018 | 02-09-2018 | Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 5800 g | Class II | Terminated |
| D-0529-2018 | 02-09-2018 | Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6); c) 500g (NDC 58597-8032-7); d)1000g (NDC 58597-8032-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 63975 g | Class II | Terminated |
| D-0484-2018 | 02-09-2018 | Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g (NDC 58597-8012-7); d) 1000g (NDC 58597-8012-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 116850 g | Class II | Terminated |
| D-0526-2018 | 02-09-2018 | Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 611400 g | Class II | Terminated |
| D-0516-2018 | 02-09-2018 | Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 6000 g | Class II | Terminated |
| D-0524-2018 | 02-09-2018 | Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 90000 g | Class II | Terminated |
| D-0504-2018 | 02-09-2018 | Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 10000 g | Class II | Terminated |
| D-0520-2018 | 02-09-2018 | Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7); d)1000g (NDC 58597-8525-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 12300 g | Class II | Terminated |
| D-0506-2018 | 02-09-2018 | Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 166000 g | Class II | Terminated |
| D-0515-2018 | 02-09-2018 | Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); b) 100g (NDC 58597-8429-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 29550 g | Class II | Terminated |
| D-0527-2018 | 02-09-2018 | Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 47500 g | Class II | Terminated |
| D-0532-2018 | 02-09-2018 | Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4); b) 100g (NDC 58597-8091-6); c) 500g (NDC 58597-8091-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 12725 g | Class II | Terminated |
| D-0485-2018 | 02-09-2018 | Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 8300 g | Class II | Terminated |
| D-0483-2018 | 02-09-2018 | Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8634-2. | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / N/A | Class II | Terminated |
| D-0477-2018 | 02-09-2018 | Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1); b) 500mg (NDC 58597-8630-2); c) 1g (NDC 58597-8630-3), Rx only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327. | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 10 g | Class II | Terminated |
| D-0476-2018 | 02-09-2018 | Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6); c) 500g (NDC 58597-8004-7); d) 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327. | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 55500 g | Class II | Terminated |
| D-0538-2018 | 02-09-2018 | Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 58597-8044-1), b) 5g (NDC 58597-8044-2), c) 25g (NDC 58597-8044-4), d) 100g (NDC 58597-8044-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / N/A | Class II | Terminated |
| D-0501-2018 | 02-09-2018 | Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8084-4); d) 25 g (NDC 58597-8084-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 240 g | Class II | Terminated |
| D-0495-2018 | 02-09-2018 | Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597-8051-6); c) 500g (NDC 58597-8051-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 26500 g | Class II | Terminated |
| D-0531-2018 | 02-09-2018 | Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 25000 g | Class II | Terminated |
| D-0487-2018 | 02-09-2018 | Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6); b)1000 g (NDC 58597-8632-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 10000 g | Class II | Terminated |
| D-0517-2018 | 02-09-2018 | Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g (NDC 58597-8028-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 20700 g | Class II | Terminated |
| D-0534-2018 | 02-09-2018 | Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); c) 1000g (NDC 58597-8039-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 50000 g | Class II | Terminated |
| D-0499-2018 | 02-09-2018 | Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) 100g (NDC 58597-8053-6); c) 500g (NDC 58597-8053-7) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 4600 g | Class II | Terminated |
| D-0518-2018 | 02-09-2018 | Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 1,050,000 g | Class II | Terminated |
| D-0528-2018 | 02-09-2018 | Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 192000 g | Class II | Terminated |
| D-0490-2018 | 02-09-2018 | Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c) 100g (NDC 58597-8048-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327. | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 3675 g | Class II | Terminated |
| D-0488-2018 | 02-09-2018 | Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8047-1); b) 5g (NDC 58597-8047-3); c) 10g (NDC 58597-8047-4); d) 25g (NDC 58597-8047-5); e) 100 g (NDC 58597-8047-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 2000 g | Class II | Terminated |
| D-0537-2018 | 02-09-2018 | Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8056-2); c) 5g (NDC 58597-8056-3); d) 10g (NDC 58597-8056-4), e) 25 g (NDC 58597-8056-4); f) 100g (NDC 58597-8056-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 10769 g | Class II | Terminated |
| D-0519-2018 | 02-09-2018 | Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 307500 g | Class II | Terminated |
| D-0510-2018 | 02-09-2018 | Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Water ford, MI 48327, NDC 58597-8055-8 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 12000 g | Class II | Terminated |
| D-0514-2018 | 02-09-2018 | Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)100g (NDC 58597-0082-6); c) 500g (NDC 58597-0082-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 24025 g | Class II | Terminated |
| D-0536-2018 | 02-09-2018 | Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g (NDC 58597-8142-3); d ) 25g (NDC 58597-8142-4), Rx only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 7255 g | Class II | Terminated |
| D-0478-2018 | 02-09-2018 | Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 48525 g | Class II | Terminated |
| D-0521-2018 | 02-09-2018 | Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4. | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 10000 g | Class II | Terminated |
| D-0508-2018 | 02-09-2018 | Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g (NDC 58597-8359-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 22900 g | Class II | Terminated |
| D-0492-2018 | 02-09-2018 | Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 106200 g | Class II | Terminated |
| D-0497-2018 | 02-09-2018 | Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (NDC 58597-8133-6); d) 1000g (NDC 58597-8133-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 52000 g | Class II | Terminated |
| D-0530-2018 | 02-09-2018 | Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 2100 g | Class II | Terminated |
| D-0502-2018 | 02-09-2018 | Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7); b) 1000g (NDC 58597-8353-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 36100 g | Class II | Terminated |
| D-0486-2018 | 02-09-2018 | Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-4); b) 100g (NDC 58597-8082-6); c) 500g (NDC 58597-8082-7); d) 1000g (NDC 58597-8082-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 75000 | Class II | Terminated |
| D-0507-2018 | 02-09-2018 | Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100g (NDC 58597-8019-6); c) 500g (NDC 58597-8019-7); d) 1000 (NDC 58597-8019-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 74000 g | Class II | Terminated |
| D-0491-2018 | 02-09-2018 | Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC 58597-8049-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 5000 g | Class II | Terminated |
| D-0505-2018 | 02-09-2018 | Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 75 g | Class II | Terminated |
| D-0481-2018 | 02-09-2018 | Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 123900 g | Class II | Terminated |
| D-0498-2018 | 02-09-2018 | Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 58597-8333-6); c) 500g (NDC 58597-8333-7); d) 1000g (NDC 58597-8333-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 191000 g | Class II | Terminated |
| D-0480-2018 | 02-09-2018 | Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-8010-2); b) 10g (NDC 58597-8010-3); c) 25g (NDC 58597-8010-4); d)100g (NDC 58597-8010-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 5000 g | Class II | Terminated |
| D-0509-2018 | 02-09-2018 | Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8021-2. | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 73 g | Class II | Terminated |
| D-0511-2018 | 02-09-2018 | Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407-2); c) 25g (NDC 58597-8407-4); d) 100g (NDC 58597-8407-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 7000 g | Class II | Terminated |
| D-0533-2018 | 02-09-2018 | Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 10000 g | Class II | Terminated |
| D-0525-2018 | 02-09-2018 | Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 33000 g | Class II | Terminated |
| D-0482-2018 | 02-09-2018 | Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g, NDC 58597-8210-6; d) 500g (NDC 58597-8210-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 13335 g | Class II | Terminated |
| D-0496-2018 | 02-09-2018 | Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (NDC 58597-8317-4) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 1638 g | Class II | Terminated |
| D-0500-2018 | 02-09-2018 | Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336-6); c) 500g (NDC 58597-8336-7); d) 1000g (NDC 58597-8336-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 225300 g | Class II | Terminated |
| D-0513-2018 | 02-09-2018 | Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 44500 g | Class II | Terminated |
| D-0489-2018 | 02-09-2018 | Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58597-8001-3); b) 25g (NDC 58597-8001-5); c)100 g (NDC 58597-8001-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 4910 g | Class II | Terminated |
| D-0523-2018 | 02-09-2018 | Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) 5g (NDC 58597-8029-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 75 g | Class II | Terminated |
| D-0512-2018 | 02-09-2018 | Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); c) 500g (NDC 58597-0081-7); d) 1000g (NDC 58597-0081-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 86225 g | Class II | Terminated |
| D-0493-2018 | 02-09-2018 | Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075-7); d) 1000g (NDC 58597-8075-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 193000 g | Class II | Terminated |
| D-0494-2018 | 02-09-2018 | Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC 58597-8014-7); d) 1000g (NDC 58597-8014-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 606950 | Class II | Terminated |
| D-0474-2018 | 02-09-2018 | Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327. | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 15000 g | Class II | Terminated |
| D-0421-2018 | 02-07-2018 | BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74 | CGMP Deviations: not manufactured according to current good manufacturing practices. | Webrx dba RxPalace.com / 1 bottle | Class III | Terminated |
| D-0597-2018 | 02-07-2018 | Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01 Package NDCs: 0409-2634-10; 0409-2634-01; 0409-2634-25; 0409-2634-05; 0409-2634-50 | Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. | Pfizer Inc. / 29, 680 vials | Class I | Terminated |
| D-0596-2018 | 02-07-2018 | Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01 Package NDCs: 0703-0110-01; 0703-0110-03; 0703-0113-01; 0703-0113-03; 0703-0018-01 | Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. | Pfizer Inc. / 53600 vials | Class I | Terminated |
| D-0417-2018 | 02-05-2018 | Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol - 389 350, Gujarat, India --- NDC 47335-779-91 Package NDCs: 47335-779-91 | Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station | Sun Pharmaceutical Industries, Inc. / 17554 bottles | Class III | Terminated |
| D-0423-2018 | 02-05-2018 | 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC | Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin. | PharMEDium Services, LLC / 21 Cassettes | Class II | Terminated |
| D-0422-2018 | 02-05-2018 | 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC | Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin. | PharMEDium Services, LLC / 24 Viaflex Bag | Class II | Terminated |
| D-0424-2018 | 02-05-2018 | 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC | Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin. | PharMEDium Services, LLC / 500 syringes | Class II | Terminated |
| D-0416-2018 | 02-05-2018 | Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01 | Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct. | Genentech, Inc. / 3,192 bottles | Class III | Terminated |
| D-0578-2018 | 02-05-2018 | Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56 | Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities. | Teva Pharmaceuticals USA / 1,157,095 bottles | Class III | Terminated |
| D-0413-2018 | 02-02-2018 | NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01. | Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label. | ALLERGAN / 8 bottles | Class III | Terminated |
| D-0427-2018 | 02-02-2018 | Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05. Package NDCs: 65862-008-50; 65862-008-60; 65862-008-90; 65862-008-01; 65862-008-33; 65862-008-05; 65862-008-99; 65862-008-45; 65862-009-50; 65862-009-60; 65862-009-90; 65862-009-01; 65862-009-33; 65862-009-05; 65862-009-99; 65862-009-44; 65862-010-50; 65862-010-60; 65862-010-90; 65862-010-01; 65862-010-33; 65862-010-05; 65862-010-99; 65862-010-46 | Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg | Aurobindo Pharma Ltd. / 7476 bottles | Class III | Terminated |
| D-0425-2018 | 01-30-2018 | VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9% Sodium Chloride to make 2.5 mg/ mL final concentration, INTRAVENOUS INJECTION ONLY add 3.5 mL Sodium Chloride to 1 mg/mL final concentration, Rx Only, Distributed by MILLENNIUM Pharmaceuticals, Inc., Cambridge, MA 02139-4234, NDC 63020-0049-01 | Defective Container: Confirmed reports of loose vial crimps. | Millennium Pharmaceuticals Inc. / 154,372 vials | Class II | Terminated |
| D-0541-2018 | 01-29-2018 | Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3212-54. | Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits | Teva Pharmaceuticals USA / 929,916 (5 pouches/carton) | Class III | Terminated |
| D-0418-2018 | 01-29-2018 | Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05 Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10 | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability | Dr. Reddy's Laboratories, Inc. / a) 34,125; b) 3,540 bottles | Class III | Terminated |
| D-0420-2018 | 01-29-2018 | Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05 Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10 | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability | Dr. Reddy's Laboratories, Inc. / 12,579 bottles | Class III | Terminated |
