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-1043-2019 | 02-28-2019 | Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-702-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India Package NDCs: 31722-700-30; 31722-700-60; 31722-700-90; 31722-700-05; 31722-700-10; 31722-701-30; 31722-701-60; 31722-701-90; 31722-701-05; 31722-701-10; 31722-702-30; 31722-702-60; 31722-702-90; 31722-702-05; 31722-702-10 | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient | Camber Pharmaceuticals Inc / 683,641 bottles | Class II | Ongoing |
| D-1041-2019 | 02-28-2019 | Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India Package NDCs: 31722-700-30; 31722-700-60; 31722-700-90; 31722-700-05; 31722-700-10; 31722-701-30; 31722-701-60; 31722-701-90; 31722-701-05; 31722-701-10; 31722-702-30; 31722-702-60; 31722-702-90; 31722-702-05; 31722-702-10 | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient | Camber Pharmaceuticals Inc / 351,732 bottles | Class II | Ongoing |
| D-1042-2019 | 02-28-2019 | Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-701-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India Package NDCs: 31722-700-30; 31722-700-60; 31722-700-90; 31722-700-05; 31722-700-10; 31722-701-30; 31722-701-60; 31722-701-90; 31722-701-05; 31722-701-10; 31722-702-30; 31722-702-60; 31722-702-90; 31722-702-05; 31722-702-10 | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient | Camber Pharmaceuticals Inc / 69712 bottles | Class II | Ongoing |
| D-1118-2019 | 02-28-2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC: 13668-117-90) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 172,296 bottles | Class II | Ongoing |
| D-0519-2019 | 02-28-2019 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD | Failed Dissolution Specifications; 9-monthstability timepoint | Jubilant Cadista Pharmaceuticals, Inc. / a) 3,072 bottles; b) 2,688 bottles | Class III | Terminated |
| D-1116-2019 | 02-28-2019 | LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 121,668 bottles | Class II | Ongoing |
| D-1115-2019 | 02-28-2019 | LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count (NDC: 13668-409-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 476,340 bottles | Class II | Ongoing |
| D-1114-2019 | 02-28-2019 | LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 133,992 bottles | Class II | Ongoing |
| D-1119-2019 | 02-28-2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 173,760 bottles | Class II | Ongoing |
| D-1117-2019 | 02-28-2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / N/A | Class II | Ongoing |
| D-0517-2019 | 02-26-2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01. Package NDCs: 68180-422-01 | Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities. | Lupin Pharmaceuticals Inc. / 674,628 bottles | Class III | Terminated |
| D-1004-2019 | 02-25-2019 | Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07 | Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. | Macleods Pharma Usa Inc / 140,589 bottles | Class II | Terminated |
| D-1003-2019 | 02-25-2019 | Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07 | Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. | Macleods Pharma Usa Inc / 93227 bottles | Class II | Terminated |
| D-1005-2019 | 02-25-2019 | Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-130-07 | Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. | Macleods Pharma Usa Inc / 134495 bottles | Class II | Terminated |
| D-1009-2019 | 02-22-2019 | Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per packet, 28-count capsules per box, MAT XI S.G Co., LTD, Head office: J29 Vo Thi Sau Street, Thong Nhat Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Manufactory: 148/9 Tan Tien Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Product distribution franshise by GoLean Detox Enterprise 002677155-A Malaysia, www.matxisg.com, UPC 8 938510 909013. | Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the US. The presence of sibutramine and phenolphthalein in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall. | Golean Detox US / 37 boxes | Class I | Terminated |
| D-0993-2019 | 02-22-2019 | Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10. | Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point. | Akorn, Inc. / 51,456 bottles | Class II | Terminated |
| D-1066-2019 | 02-22-2019 | Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05. Package NDCs: 67877-450-30; 67877-450-60; 67877-450-01; 67877-450-05; 67877-450-10; 67877-450-33; 67877-450-38 | Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing. | Ascend Laboratories LLC / 3,072 bottles | Class II | Terminated |
| D-1107-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 3 prescriptions, 5ml injectable | Class II | Terminated |
| D-0996-2019 | 02-21-2019 | Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37 Package NDCs: 62175-270-37; 62175-270-41; 62175-271-37; 62175-271-41; 62175-272-37; 62175-272-41 | Failed Dissolution Specifications | Lannett Company Inc. / 14,448 bottles | Class III | Terminated |
| D-1087-2019 | 02-21-2019 | DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 12 prescriptions | Class II | Terminated |
| D-1100-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 9ml injectable | Class II | Terminated |
| D-1095-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 2 prescription 5ml injection | Class II | Terminated |
| D-1101-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 5ml injectable | Class II | Terminated |
| D-1092-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 3 prescriptions 10, 9, ml injection | Class II | Terminated |
| D-1105-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 2 prescriptions, 5ml injection | Class II | Terminated |
| D-1091-2019 | 02-21-2019 | PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) 6ml (d) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 5 prescriptions 5,10, 6, 9 ml injectable | Class II | Terminated |
| D-1109-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 5ml | Class II | Terminated |
| D-1097-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 3 prescription 5, 10 ml injection | Class II | Terminated |
| D-1088-2019 | 02-21-2019 | ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 6 prescriptions 10ml dropper bottle | Class II | Terminated |
| D-1086-2019 | 02-21-2019 | SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription 20ml solution | Class II | Terminated |
| D-1099-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription 9ml injectable | Class II | Terminated |
| D-1104-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription 9ml injection | Class II | Terminated |
| D-1096-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 2 prescription 5, 6.5 ml injection | Class II | Terminated |
| D-1106-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 18ml injection | Class II | Terminated |
| D-1103-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 16.6-0.55 MG-11.1 MCG/ML* INJECTABLE, 10 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 2 pre4scriptions 10 ml injections | Class II | Terminated |
| D-1094-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 9 prescriptions 10, 9ml injection | Class II | Terminated |
| D-1110-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 5ml injection | Class II | Terminated |
| D-1098-2019 | 02-21-2019 | PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 25 prescriptions 10, 9, ml injectable | Class II | Terminated |
| D-1102-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 9ml injection | Class II | Terminated |
| D-1089-2019 | 02-21-2019 | HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 4 prescriptions 9 & 10ml injectable | Class II | Terminated |
| D-1093-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 13 prescription 5, 6, 9, 10 ml injection | Class II | Terminated |
| D-1090-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 64 prescriptions 5, 10, 6 mL injections | Class II | Terminated |
| D-1108-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 15-0.25MG-6MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 5ml injection | Class II | Terminated |
| D-1040-2019 | 02-21-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10 | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. | Macleods Pharma Usa Inc / 9695 bottles | Class II | Terminated |
| D-0520-2019 | 02-20-2019 | Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent 32 Fl. Oz. (1 QT) 946 mL bottle, Distributed By: Discount Drug Mart 211 Commerce Drive, Medina, Ohio 44256 NDC 53943-871-45 UPC 0-93351-12758-8 | Cross Contamination: Presence of IPA in finished product. | Vi-Jon, Inc. / 6756 32 oz bottles | Class II | Terminated |
| D-1584-2019 | 02-19-2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories. Package NDCs: 68001-314-00; 68001-314-08; 68001-315-00; 68001-315-08; 68001-316-00; 68001-316-08 | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results. | American Health Packaging / 14,360 bottles | Class III | Terminated |
| D-0518-2019 | 02-19-2019 | Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 292-6772- 17 Great Oaks Blvd., San Jose, CA 95119. NDC: 70360-007-35. | Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride. | Leiter's Enterprises, Inc. / 569 vials | Class II | Terminated |
| D-0516-2019 | 02-19-2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071 | Failed dissolution specifications | Amerigen Pharmaceuticals Inc. / a) 2,413 bottles b) 3,355 bottles | Class III | Terminated |
| D-1065-2019 | 02-15-2019 | Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31 | Subpotent Drug. | Heritage Pharmaceuticals, Inc. / 11888 units | Class II | Terminated |
| D-0821-2020 | 02-14-2019 | Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704 | Presence of Particulate Matter: Particulates observed in vials release for dispensing. | McGuff Compounding Pharmacy Services, Inc. / N/A | Class II | Terminated |
| D-0989-2019 | 02-13-2019 | Maeng Da Kratom, packaged in a) 20 count capsules (UPC 00859667007149), b) 60 count capsules (UPC 00859667007156), c) 150 count capsules (UPC 00859667007163) , Sunstone Organics Springfield, Oregon 97473, 541-972-3327. | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Todd Holiday dba Sunstone Organics / N/A | Class I | Terminated |
| D-0987-2019 | 02-13-2019 | White Vein Kratom, packaged in a) 25 gram powder (UPC 00859667007316), b) 50 gram powder (UPC 00859667007323), c) 100 gram powder (UPC 00859667007330), Sunstone Organics Springfield, Oregon 97473, 541-972-3327. | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Todd Holiday dba Sunstone Organics / 250 Kilograms | Class I | Terminated |
| D-0986-2019 | 02-13-2019 | Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gram powder (UPC 00859667007125), c) 100 gram powder (UPC 00859667007132), Sunstone Organics Springfield, Oregon 97473, 541-972-3327. | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Todd Holiday dba Sunstone Organics / 800 kilograms | Class I | Terminated |
| D-0988-2019 | 02-13-2019 | White Vein Kratom, packaged in a) 20 count capsules (UPC 00859667007347), b) 60 count capsules (UPC 00859667007354), c) 150 count capsules (UPC 00859667007361), Sunstone Organics Springfield, Oregon 97473 541-972-3327. | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Todd Holiday dba Sunstone Organics / N/A | Class I | Terminated |
| D-0513-2019 | 02-13-2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA. Package NDCs: 68180-467-09; 68180-467-07; 68180-467-01; 68180-467-03; 68180-467-05; 68180-468-07; 68180-468-01; 68180-468-03; 68180-468-05; 68180-468-09; 68180-469-07; 68180-469-01; 68180-469-03; 68180-469-05; 68180-469-09 | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results. | Lupin Pharmaceuticals Inc. / 44,640 bottles | Class III | Terminated |
| D-0512-2019 | 02-13-2019 | Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09 Package NDCs: 45802-401-09 | Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing. | Perrigo New York, Inc. / 12252 bottles | Class III | Terminated |
| D-0506-2019 | 02-13-2019 | Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505 | Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing | Mylan Pharmaceuticals Inc. / 8,159 bottles | Class III | Terminated |
| D-1111-2019 | 02-08-2019 | Indian Herb Paste (a dietary supplement) Ingredients: Galangal, Indian Paint, Yellow Dock & Licorice in an alloy of Life-Line tm and Zinc Chloride in 6 dram vials, McDaniel Life-Line LLC, Dimmitt, TX | Unapproved new drug | McDaniel Life-Line LLC / 150 vials | Class II | Terminated |
| D-1000-2019 | 02-08-2019 | MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella Specialty Pharmacy 24416 N 19 th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-907-05. | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself. | Avella of Deer Valley, Inc. Store 38 / 8,500 54 mL bags | Class II | Terminated |
| D-0998-2019 | 02-08-2019 | MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-901-05. | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself. | Avella of Deer Valley, Inc. Store 38 / 250 52 mL bags | Class II | Terminated |
| D-1112-2019 | 02-08-2019 | Life-Line tm Catalytic Activated Energy Water, 1 gallon container, McDaniel Life-Line LLC 1775 US Hwy 385 806-647-1741 Dimmitt, TX 79027 | Unapproved new drug | McDaniel Life-Line LLC / Unknown | Class II | Terminated |
| D-0997-2019 | 02-08-2019 | Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-822-71. | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself. | Avella of Deer Valley, Inc. Store 38 / 2,840 4mL syringes | Class II | Terminated |
| D-0999-2019 | 02-08-2019 | MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-902-05. | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself. | Avella of Deer Valley, Inc. Store 38 / 4,950 54 mL bags | Class II | Terminated |
| D-0514-2019 | 02-07-2019 | Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37 | Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error. | ACP Nimble Buyer, Inc. / 58,176 units | Class III | Terminated |
| D-0496-2019 | 02-06-2019 | Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-210-72 | Labeling: Incorrect expiration date. | Advanced Pharma Inc. / 100 syringes | Class II | Terminated |
| D-0497-2019 | 02-06-2019 | Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99. | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. | Advanced Pharma Inc. / 12 bags | Class III | Terminated |
| D-1064-2019 | 02-06-2019 | Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49 | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. | Ecolab Inc / 105 units | Class II | Terminated |
| D-0498-2019 | 02-06-2019 | Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99. | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. | Advanced Pharma Inc. / 672 bags | Class III | Terminated |
| D-0499-2019 | 02-06-2019 | Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50. | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. | Advanced Pharma Inc. / 1460 bottles | Class III | Terminated |
| D-0995-2019 | 02-06-2019 | Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA. Package NDCs: 43598-509-30; 43598-509-90; 43598-509-10; 43598-510-30; 43598-510-90; 43598-510-10 | Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets. | Dr. Reddy's Laboratories, Inc. / 40,592, 90 and 1,000 count bottles | Class III | Terminated |
| D-1062-2019 | 02-06-2019 | Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-489-33 Package NDCs: 47593-489-26; 47593-489-33; 47593-489-49; 47593-489-31; 47593-489-55 | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. | Ecolab Inc / 30 units | Class II | Terminated |
| D-1060-2019 | 02-06-2019 | Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz) bottles (NDC 47593-487-33), and c) 540 mL (18 fl oz) bottles (NDC47593-487-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. Package NDCs: 47593-487-33; 47593-487-31; 47593-487-41; 47593-487-26; 47593-487-49; 47593-487-56; 47593-487-55; 47593-487-65; 47593-487-38; 47593-487-35; 47593-487-11; 47593-487-91 | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. | Ecolab Inc / a) 22 units b) 314 units c) 3511 units | Class II | Terminated |
| D-1061-2019 | 02-06-2019 | Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540 mL (18 fl oz) bottles (NDC 47593-488-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. Package NDCs: 47593-488-33; 47593-488-31; 47593-488-32; 47593-488-26; 47593-488-56; 47593-488-41; 47593-488-49 | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. | Ecolab Inc / a) 118 units, b) 3,783 units | Class II | Terminated |
| D-1063-2019 | 02-06-2019 | Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-491-85 | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. | Ecolab Inc / 67 units | Class II | Terminated |
| D-0509-2019 | 02-04-2019 | 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09 | CGMP Deviations | ICU Medical Inc / 475320 bags | Class II | Terminated |
| D-0511-2019 | 02-04-2019 | Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01. | Failed Stability Specification: out of specification results for Sodium Perborate | Akorn Inc / 78120 dropper bottles | Class II | Terminated |
| D-0484-2019 | 02-01-2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01 Package NDCs: 68180-422-01 | Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained. | Lupin Pharmaceuticals Inc. / 43,860 3ml bottles | Class III | Terminated |
| D-0424-2019 | 02-01-2019 | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23. Package NDCs: 0037-0245-23 | Defective Container: Potential for broken glass in the neck area of the glass bottles. | Mylan Pharmaceuticals Inc. / 10,390 bottles | Class II | Terminated |
| D-1059-2019 | 02-01-2019 | Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30 | Presence of Particulate Matter: particulate matter identified as copper salts | Mylan Institutional Inc / 11,964 cartons of 30 vials | Class I | Terminated |
| D-0507-2019 | 01-31-2019 | Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01 Package NDCs: 55111-533-30; 55111-533-60; 55111-533-01; 55111-533-05; 55111-533-79; 55111-533-78 | Failed Dissolution Specifications: Out of specification results observed for high dissolution. | Dr. Reddy's Laboratories, Inc. / 10,656 bottles | Class II | Terminated |
| D-0490-2019 | 01-30-2019 | Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); and b) 90-count bottles (NDC 0187-0798-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada. Package NDCs: 0187-0795-30; 0187-0795-42; 0187-0795-49; 0187-0796-30; 0187-0796-42; 0187-0796-49; 0187-0796-50; 0187-0797-30; 0187-0797-42; 0187-0797-49; 0187-0798-30; 0187-0798-42; 0187-0799-42 | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. | Valeant Pharmaceuticals North America LLC / 22 bottles | Class III | Terminated |
| D-0489-2019 | 01-30-2019 | Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottles (NDC 0187-0797-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada. Package NDCs: 0187-0795-30; 0187-0795-42; 0187-0795-49; 0187-0796-30; 0187-0796-42; 0187-0796-49; 0187-0796-50; 0187-0797-30; 0187-0797-42; 0187-0797-49; 0187-0798-30; 0187-0798-42; 0187-0799-42 | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. | Valeant Pharmaceuticals North America LLC / 390 bottles | Class III | Terminated |
| D-0487-2019 | 01-30-2019 | Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada. Package NDCs: 0187-0795-30; 0187-0795-42; 0187-0795-49; 0187-0796-30; 0187-0796-42; 0187-0796-49; 0187-0796-50; 0187-0797-30; 0187-0797-42; 0187-0797-49; 0187-0798-30; 0187-0798-42; 0187-0799-42 | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. | Valeant Pharmaceuticals North America LLC / 1023 bottles | Class III | Terminated |
| D-0488-2019 | 01-30-2019 | Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada. Package NDCs: 0187-0795-30; 0187-0795-42; 0187-0795-49; 0187-0796-30; 0187-0796-42; 0187-0796-49; 0187-0796-50; 0187-0797-30; 0187-0797-42; 0187-0797-49; 0187-0798-30; 0187-0798-42; 0187-0799-42 | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. | Valeant Pharmaceuticals North America LLC / 206 bottles | Class III | Terminated |
| D-0491-2019 | 01-30-2019 | Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-521-01. | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. | Valeant Pharmaceuticals North America LLC / 23,884 bottles | Class III | Terminated |
| D-0508-2019 | 01-29-2019 | Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407 | Lack of assurance of sterility. | US Compounding Inc / 1686 syringes | Class II | Terminated |
| D-0429-2019 | 01-28-2019 | Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA. | Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities. | Lupin Pharmaceuticals Inc. / 9,930 bottles | Class III | Terminated |
| D-0500-2019 | 01-25-2019 | the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, Piperine), 10 count mylar package, Nature's Rx, Claremont, CA | Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil | Natures Rx / 211 | Class I | Terminated |
| D-0515-2019 | 01-25-2019 | Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701. | Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study. | Akorn Inc / a) 4896 tubes; b) 5064 tubes | Class III | Terminated |
| D-0422-2019 | 01-24-2019 | BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41 Package NDCs: 49708-754-41 | Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance. | Sun Pharmaceutical Industries, Inc. / 69840 bottles | Class II | Terminated |
| D-0482-2019 | 01-24-2019 | LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compounding, 1270 Don's Lane, Conway, AR, 800-718-3588, Barcode 62295501303. | Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY. | US Compounding Inc / 1931 syringes | Class II | Terminated |
| D-1013-2019 | 01-18-2019 | Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20 | Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 10,281 UD cartons | Class II | Terminated |
| D-0428-2019 | 01-18-2019 | Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. | Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification. | Mylan Pharmaceuticals Inc. / 88,090 bottles | Class II | Terminated |
| D-0409-2019 | 01-18-2019 | Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09 Package NDCs: 43547-374-03; 43547-374-09; 43547-374-50; 43547-375-03; 43547-375-09; 43547-375-50; 43547-376-03; 43547-376-09; 43547-376-50 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Prinston Pharmaceutical Inc / 19800 bottles | Class II | Completed |
| D-0410-2019 | 01-18-2019 | Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-09 Package NDCs: 43547-330-03; 43547-330-09; 43547-330-50; 43547-331-03; 43547-331-09; 43547-331-50 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Prinston Pharmaceutical Inc / 2177 bottles | Class II | Completed |
| D-0413-2019 | 01-18-2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-03 Package NDCs: 43547-330-03; 43547-330-09; 43547-330-50; 43547-331-03; 43547-331-09; 43547-331-50 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Prinston Pharmaceutical Inc / 87505 bottles | Class II | Completed |
| D-0412-2019 | 01-18-2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 90 count NDC 43547-331-09 Package NDCs: 43547-330-03; 43547-330-09; 43547-330-50; 43547-331-03; 43547-331-09; 43547-331-50 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Prinston Pharmaceutical Inc / 12294 bottles | Class II | Completed |
| D-0411-2019 | 01-18-2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 30 count - NDC 43547-331-03 Package NDCs: 43547-330-03; 43547-330-09; 43547-330-50; 43547-331-03; 43547-331-09; 43547-331-50 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Prinston Pharmaceutical Inc / 32692 bottles | Class II | Completed |
| D-1078-2019 | 01-16-2019 | NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343 | Labeling: Label mix-up | KRS Global Biotechnology, Inc / 190 250 mL bags | Class II | Terminated |
| D-1079-2019 | 01-16-2019 | NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481 | Labeling: Label mix-up | KRS Global Biotechnology, Inc / 433 250 mL bags | Class II | Terminated |
