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-0825-2022 | 04-04-2022 | Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0058-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1276 vials | Class II | Terminated |
| D-0820-2022 | 04-04-2022 | T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0022-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1097 vials | Class II | Terminated |
| D-0802-2022 | 04-04-2022 | AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0039-10 | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 310 vials | Class II | Terminated |
| D-0826-2022 | 04-04-2022 | Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0080-30. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 6431 vials | Class II | Terminated |
| D-0800-2022 | 04-04-2022 | Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0004-10 | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 800 vials | Class II | Terminated |
| D-0822-2022 | 04-04-2022 | Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0021-05. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 4521 vials | Class II | Terminated |
| D-0811-2022 | 04-04-2022 | QM-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0019-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1679 vials | Class II | Terminated |
| D-0803-2022 | 04-04-2022 | NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10 | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 3509 vials | Class II | Terminated |
| D-0801-2022 | 04-04-2022 | AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0040-10 | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1318 vials | Class II | Terminated |
| D-0799-2022 | 04-04-2022 | T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835 . | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 6916 vials | Class II | Terminated |
| D-0816-2022 | 04-04-2022 | FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0006-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2887 vials | Class II | Terminated |
| D-0813-2022 | 04-04-2022 | RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0015-10; b) 2.5 mL Multi-Dose vial, NDC 73198-0015-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1849 vials | Class II | Terminated |
| D-0798-2022 | 04-04-2022 | QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0018-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1871 vials | Class II | Terminated |
| D-1149-2022 | 04-04-2022 | HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Distributed by: Hand Cleansing Gel 850 Kaliste Saloom Rd. Suite 212 Lafayette, LA 70508 UPC 8 60003 62626 9 | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Hand Sanitizer LLC / 24,020 bottles | Class II | Terminated |
| D-0807-2022 | 04-04-2022 | SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0024-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1110 vials | Class II | Terminated |
| D-0795-2022 | 04-04-2022 | NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00 | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 16,329 vials | Class II | Terminated |
| D-0815-2022 | 04-04-2022 | BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0027-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 388 vials | Class II | Terminated |
| D-0810-2022 | 04-04-2022 | ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0012-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2005 vials | Class II | Terminated |
| D-0819-2022 | 04-04-2022 | PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0030-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 410 vials | Class II | Terminated |
| D-0806-2022 | 04-04-2022 | SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0023-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1740 vials | Class II | Terminated |
| D-0827-2022 | 04-04-2022 | Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0082-00. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1770 vials | Class II | Terminated |
| D-0809-2022 | 04-04-2022 | ST-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0011-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 525 vials | Class II | Terminated |
| D-0541-2023 | 04-01-2022 | CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx | Marketed Without an Approved NDA/ANDA | Wellness BioSciences / 2000 inhalers | Class II | Ongoing |
| D-0861-2022 | 04-01-2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16 | Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 885 cartons | Class II | Terminated |
| D-0860-2022 | 04-01-2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16 | Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 555 cartons | Class II | Terminated |
| D-0748-2022 | 04-01-2022 | Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32. Package NDCs: 0378-9651-32; 0378-9651-50 | Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing. | Mylan Pharmaceuticals Inc / 20,112 bottles | Class II | Terminated |
| D-0752-2022 | 04-01-2022 | Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06 | Subpotent | Jubilant Cadista Pharmaceuticals, Inc. / 19,222 Bottles (100-count) | Class III | Terminated |
| D-0770-2022 | 04-01-2022 | Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96 Package NDCs: 47335-506-96; 47335-507-97 | Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter. | SUN PHARMACEUTICAL INDUSTRIES INC / 73,030 boxes | Class III | Terminated |
| D-0745-2022 | 04-01-2022 | 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx Only, RITEDOSE, 503B Outsourcing Facility, A Division of the RITEDOSE Corporation, 1 Technology Circle, Columbia, SC 29203, 1-866-994-4670, NDC: 65302-509-30, barcode N (01) 003 65302 50930 0 | Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL. | The Ritedose Corporation / 3795 syringes | Class III | Terminated |
| D-0843-2022 | 03-31-2022 | Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA Package NDCs: 68180-215-09; 68180-215-03; 68180-215-01; 68180-215-06; 68180-216-06; 68180-216-09; 68180-216-01; 68180-216-03; 68180-217-06; 68180-217-09; 68180-217-01; 68180-217-03 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. / 2,361,924 bottles | Class II | Terminated |
| D-0842-2022 | 03-31-2022 | Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA Package NDCs: 68180-215-09; 68180-215-03; 68180-215-01; 68180-215-06; 68180-216-06; 68180-216-09; 68180-216-01; 68180-216-03; 68180-217-06; 68180-217-09; 68180-217-01; 68180-217-03 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. / 303,696 bottles | Class II | Terminated |
| D-0746-2022 | 03-31-2022 | Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale, Rx Only, Manufactured for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA, by Patheon Puerto Rico, Inc. Manati, Puerto Rico, 00674 Bottle (NDC 0006-0575-02), Carton (NDC 0006-0575-03) Package NDCs: 0006-0575-82; 0006-0575-61; 0006-0575-62; 0006-0575-01; 0006-0575-52; 0006-0575-56; 0006-0575-02; 0006-0575-03; 0006-0577-61; 0006-0577-62; 0006-0577-82; 0006-0577-01; 0006-0577-52; 0006-0577-56; 0006-0577-02; 0006-0577-03 | Presence of foreign substance: Presence of stainless steel particulates in tablets. | MERCK SHARP & DOHME CORP / 3600 cartons | Class II | Terminated |
| D-0841-2022 | 03-31-2022 | Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA. Package NDCs: 68180-215-09; 68180-215-03; 68180-215-01; 68180-215-06; 68180-216-06; 68180-216-09; 68180-216-01; 68180-216-03; 68180-217-06; 68180-217-09; 68180-217-01; 68180-217-03 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. / 1,214,016 bottles | Class II | Terminated |
| D-0840-2022 | 03-31-2022 | Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA. Package NDCs: 68180-210-09; 68180-210-03; 68180-210-01; 68180-210-06; 68180-211-06; 68180-211-09; 68180-211-03; 68180-211-01; 68180-212-06; 68180-212-03; 68180-212-09; 68180-212-01; 68180-376-03; 68180-376-06; 68180-376-01; 68180-376-09; 68180-377-03; 68180-377-01; 68180-377-09; 68180-377-06; 68180-378-09; 68180-378-03; 68180-378-06; 68180-378-01; 68180-307-01; 68180-307-02; 68180-307-09; 68180-307-06; 68180-308-06; 68180-308-09; 68180-308-02; 68180-308-01; 68180-309-06; 68180-309-09; 68180-309-02; 68180-309-01 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. / 1,247,067 bottles | Class II | Terminated |
| D-0839-2022 | 03-31-2022 | Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA. Package NDCs: 68180-210-09; 68180-210-03; 68180-210-01; 68180-210-06; 68180-211-06; 68180-211-09; 68180-211-03; 68180-211-01; 68180-212-06; 68180-212-03; 68180-212-09; 68180-212-01; 68180-376-03; 68180-376-06; 68180-376-01; 68180-376-09; 68180-377-03; 68180-377-01; 68180-377-09; 68180-377-06; 68180-378-09; 68180-378-03; 68180-378-06; 68180-378-01; 68180-307-01; 68180-307-02; 68180-307-09; 68180-307-06; 68180-308-06; 68180-308-09; 68180-308-02; 68180-308-01; 68180-309-06; 68180-309-09; 68180-309-02; 68180-309-01 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. / 1,466,150 bottles | Class II | Terminated |
| D-0838-2022 | 03-31-2022 | Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA. Package NDCs: 68180-210-09; 68180-210-03; 68180-210-01; 68180-210-06; 68180-211-06; 68180-211-09; 68180-211-03; 68180-211-01; 68180-212-06; 68180-212-03; 68180-212-09; 68180-212-01; 68180-376-03; 68180-376-06; 68180-376-01; 68180-376-09; 68180-377-03; 68180-377-01; 68180-377-09; 68180-377-06; 68180-378-09; 68180-378-03; 68180-378-06; 68180-378-01; 68180-307-01; 68180-307-02; 68180-307-09; 68180-307-06; 68180-308-06; 68180-308-09; 68180-308-02; 68180-308-01; 68180-309-06; 68180-309-09; 68180-309-02; 68180-309-01 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. / 657,336 bottles | Class II | Terminated |
| D-0211-2024 | 03-30-2022 | Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate (19.1%), packaged in 6 oz. cans, Unilever, Dist. By Unilever, Trumbull, CT 06611 UPC 0 79400 78550 3 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | Unilever United States Inc. / unknown | Class II | Ongoing |
| D-0210-2024 | 03-30-2022 | Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chlorohydrate (19.1%), packaged in a) 4 oz. cans (UPC 0 79400 75150 8), and b) 6 oz. cans (UPC 0 79400 78490 2), Dist. By Unilever, Trumbull, CT 06611 | Chemical contamination: presence of benzene | Unilever United States Inc. / unknown | Class I | Ongoing |
| D-0787-2022 | 03-29-2022 | Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0324-28. | Incorrect/Undeclared Excipient: Product contains alcohol | AptaPharma Inc. / 40000 - 50000 units | Class III | Terminated |
| D-0877-2022 | 03-29-2022 | The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-012-02 | Chemical Contamination; FDA analysis found product to contain benzene | Best Brands Consumer Products, Inc. / 346,320 bottles | Class I | Terminated |
| D-0876-2022 | 03-29-2022 | Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-013-02 | Chemical Contamination; FDA analysis found product to contain methanol | Best Brands Consumer Products, Inc. / 44,640 bottles | Class I | Terminated |
| D-0785-2022 | 03-29-2022 | Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6. | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Pink Toyz / 120 blister cards | Class I | Terminated |
| D-0765-2022 | 03-29-2022 | IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11. | Presence of Particulate Matter: Product was found to contain silica and iron oxide | Teva Pharmaceuticals USA Inc / 1565 vials | Class I | Terminated |
| D-0769-2022 | 03-28-2022 | Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delayed-Release Capsules, 15mg, Generic for Prevacid, 90-Count Bottle, Manufacturer: Dr Reddy's Laboratories Limited, NDC 68788-6390-09 | Out of specification results observed in dissolution during long term stability testing. | Preferred Pharmaceuticals, Inc. / 791 bottles of 90 - Count | Class II | Terminated |
| D-0771-2022 | 03-24-2022 | Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican's Solution, Mfg: Teligent Pharma, Inc., NDC 68788-7406-03 | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program. | Preferred Pharmaceuticals, Inc. / 41 Tubes | Class II | Terminated |
| D-0870-2022 | 03-24-2022 | MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73. | CGMP Deviations: Failure to properly investigate failed microbial testing. | Plastikon Healthcare LLC / 5,400 Unit Dose cups | Class II | Completed |
| D-0868-2022 | 03-24-2022 | Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73. | Microbial Contamination of Non-Sterile Products | Plastikon Healthcare LLC / 23,300 Unit Dose cups | Class I | Completed |
| D-0867-2022 | 03-24-2022 | MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73. | Microbial Contamination of Non-Sterile Products | Plastikon Healthcare LLC / 14,100 Unit Dose cups | Class I | Completed |
| D-0869-2022 | 03-24-2022 | Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76. | CGMP Deviations: Failure to properly investigate failed microbial testing. | Plastikon Healthcare LLC / 121,800 Unit Dose cups | Class II | Completed |
| D-0871-2022 | 03-24-2022 | Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73. | CGMP Deviations: Failure to properly investigate failed microbial testing. | Plastikon Healthcare LLC / 106,400 Unit Dose cups | Class II | Completed |
| D-0773-2022 | 03-24-2022 | Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01 | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program. | Preferred Pharmaceuticals, Inc. / 528 bottles | Class II | Terminated |
| D-0738-2022 | 03-23-2022 | Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90. Package NDCs: 55111-398-30; 55111-398-60; 55111-398-90; 55111-398-01; 55111-398-05; 55111-398-79; 55111-399-30; 55111-399-60; 55111-399-90; 55111-399-01; 55111-399-05; 55111-399-79 | Failed Dissolution Specifications; during long term stability testing. | Dr. Reddy's Laboratories, Inc. / 7,703 bottles | Class II | Terminated |
| D-0768-2022 | 03-23-2022 | Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED Pharmaceuticals, Inc., The Physician's Solution, NDC 68788-7768-01 | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program. | Preferred Pharmaceuticals, Inc. / 1568 bottles | Class II | Terminated |
| D-0735-2022 | 03-23-2022 | TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 17 vials | Class II | Terminated |
| D-0728-2022 | 03-23-2022 | GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 6017 vials | Class II | Terminated |
| D-0734-2022 | 03-23-2022 | TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 24 vials | Class II | Terminated |
| D-0729-2022 | 03-23-2022 | (CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 1843 vials | Class II | Terminated |
| D-0737-2022 | 03-23-2022 | Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India Package NDCs: 55111-398-30; 55111-398-60; 55111-398-90; 55111-398-01; 55111-398-05; 55111-398-79; 55111-399-30; 55111-399-60; 55111-399-90; 55111-399-01; 55111-399-05; 55111-399-79 | Failed Dissolution Specifications; during long term stability testing. | Dr. Reddy's Laboratories, Inc. / 8,352 bottles (30-count), 1,368 bottles (90-count) | Class II | Terminated |
| D-0731-2022 | 03-23-2022 | TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML Formula ID 136164; b) (RM) 10 ML Formula ID 115962; APS Phar | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 73 vials | Class II | Terminated |
| D-0732-2022 | 03-23-2022 | TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 620 vials | Class II | Terminated |
| D-0730-2022 | 03-23-2022 | TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 846 vials | Class II | Terminated |
| D-0733-2022 | 03-23-2022 | TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable, Packaged in a multi dose 10ml vial, Formula ID 115498, APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 0 | Class II | Terminated |
| D-0760-2022 | 03-21-2022 | quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1 | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 1104 bottles | Class II | Terminated |
| D-0755-2022 | 03-21-2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23 | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 160 bottles | Class II | Terminated |
| D-0757-2022 | 03-21-2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23. | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 265 bottles | Class II | Terminated |
| D-0759-2022 | 03-21-2022 | quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1 | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 21108 bottles | Class II | Terminated |
| D-0756-2022 | 03-21-2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23. | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 1364 bottles | Class II | Terminated |
| D-0751-2022 | 03-21-2022 | The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (500 mL, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC Code 714132000714. | Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC | Revive Personal Products Company / 6156 bottles | Class II | Terminated |
| D-0754-2022 | 03-21-2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23. | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 53 bottles | Class II | Terminated |
| D-0761-2022 | 03-21-2022 | Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 . | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 195 bottles | Class II | Terminated |
| D-0764-2022 | 03-21-2022 | SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-131-02. | Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine. | Adamis Pharmaceuticals Corporation / 2,500 cartons | Class I | Terminated |
| D-0763-2022 | 03-21-2022 | SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-130-02 | Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine. | Adamis Pharmaceuticals Corporation / 25,103 cartons | Class I | Terminated |
| D-0753-2022 | 03-21-2022 | Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01. Package NDCs: 0185-0022-10; 0185-0022-01 | CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. | Sandoz, Inc / 7908 bottles(790,800 extended release tablets) | Class II | Terminated |
| D-0758-2022 | 03-21-2022 | quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9 | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 2442 bottles | Class II | Terminated |
| D-0747-2022 | 03-18-2022 | NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of 1,10-phenanthroline, 6 mcg of Gentisic acid, 20 mg of D-Mannitol, and Nitrogen; and Vial 2, 1 Single dose vial of reaction buffer, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc., by: Gipharma S.r.l., Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40 Package NDCs: 69488-001-40 | Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies. | Advanced Accelerator Applications USA, Inc. / 14,089 kits | Class III | Terminated |
| D-0736-2022 | 03-17-2022 | Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01. Package NDCs: 13107-014-01; 13107-015-01 | Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room. | Aurolife Pharma, LLC / 4080 bottles | Class II | Terminated |
| D-1180-2022 | 03-16-2022 | Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA. Package NDCs: 60429-183-30; 60429-183-10; 60429-183-90; 60429-184-30; 60429-184-10; 60429-184-90; 60429-185-30; 60429-185-10; 60429-185-90; 60429-186-30; 60429-186-10; 60429-186-90 | CGMP Deviations | Golden State Medical Supply Inc. / 1,424 bottles | Class II | Ongoing |
| D-1177-2022 | 03-16-2022 | Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA. Package NDCs: 60429-183-30; 60429-183-10; 60429-183-90; 60429-184-30; 60429-184-10; 60429-184-90; 60429-185-30; 60429-185-10; 60429-185-90; 60429-186-30; 60429-186-10; 60429-186-90 | CGMP Deviations | Golden State Medical Supply Inc. / 1,471 bottles | Class II | Ongoing |
| D-1178-2022 | 03-16-2022 | Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA. Package NDCs: 60429-183-30; 60429-183-10; 60429-183-90; 60429-184-30; 60429-184-10; 60429-184-90; 60429-185-30; 60429-185-10; 60429-185-90; 60429-186-30; 60429-186-10; 60429-186-90 | CGMP Deviations | Golden State Medical Supply Inc. / 9,058 | Class II | Ongoing |
| D-1179-2022 | 03-16-2022 | Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA. Package NDCs: 60429-183-30; 60429-183-10; 60429-183-90; 60429-184-30; 60429-184-10; 60429-184-90; 60429-185-30; 60429-185-10; 60429-185-90; 60429-186-30; 60429-186-10; 60429-186-90 | CGMP Deviations | Golden State Medical Supply Inc. / 31,260 bottles | Class II | Ongoing |
| D-0726-2022 | 03-16-2022 | Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90 Package NDCs: 55111-124-30; 55111-124-60; 55111-124-90; 55111-124-05 | Failed Impurities/Degradation Specifications: Out of Specification results for related substance. | Dr. Reddy's Laboratories, Inc. / 28,068 bottles | Class III | Terminated |
| D-0695-2022 | 03-15-2022 | Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 217,184 tubes | Class II | Terminated |
| D-0696-2022 | 03-15-2022 | Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 159,994 tubes | Class II | Terminated |
| D-0689-2022 | 03-15-2022 | Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 161,331 tubes | Class II | Terminated |
| D-0669-2022 | 03-15-2022 | Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310 | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 43,218 bottles | Class II | Terminated |
| D-0686-2022 | 03-15-2022 | Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 355,672 tubes | Class II | Terminated |
| D-0690-2022 | 03-15-2022 | Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 6431 bottles | Class II | Terminated |
| D-0682-2022 | 03-15-2022 | Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 151,975 tubes | Class II | Terminated |
| D-0694-2022 | 03-15-2022 | Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-008-14. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 100,256 tubes | Class II | Terminated |
| D-0692-2022 | 03-15-2022 | Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 30,497 bottles | Class II | Terminated |
| D-0677-2022 | 03-15-2022 | Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 54,897 tubes | Class II | Terminated |
| D-0702-2022 | 03-15-2022 | Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810, NDC 70512-036-30. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 31,489 tubes | Class II | Terminated |
| D-0697-2022 | 03-15-2022 | Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 721,225 tubes; 90,893 jars | Class II | Terminated |
| D-0675-2022 | 03-15-2022 | Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 36,426 tubes | Class II | Terminated |
| D-0688-2022 | 03-15-2022 | Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-033-50. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 35,185 tubes | Class II | Terminated |
| D-0681-2022 | 03-15-2022 | Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-031-60. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 24,304 bottles | Class II | Terminated |
| D-0678-2022 | 03-15-2022 | Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 13,989 tubes | Class II | Terminated |
| D-0693-2022 | 03-15-2022 | Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tubes, NDC 52565-122-30; c) 5 x 5 gram tubes, NDC 52565-122-07; Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310; Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 136,960 tubes | Class II | Terminated |
| D-0676-2022 | 03-15-2022 | Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 6850 tubes | Class II | Terminated |
| D-0673-2022 | 03-15-2022 | Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 72,826 tubes | Class II | Terminated |
