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-1836-2019 | 07-29-2019 | Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00 Package NDCs: 0832-0285-00 | Failed Dissolution Specifications | Upsher Smith Laboratories, Inc. / 166 bottles | Class II | Terminated |
| D-1842-2019 | 07-29-2019 | Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99 Package NDCs: 65862-050-30; 65862-050-45; 65862-050-90; 65862-050-01; 65862-050-00; 65862-050-99; 65862-050-26; 65862-051-30; 65862-051-45; 65862-051-90; 65862-051-01; 65862-051-00; 65862-051-99; 65862-051-26; 65862-052-30; 65862-052-45; 65862-052-90; 65862-052-01; 65862-052-00; 65862-052-99; 65862-052-26; 65862-053-30; 65862-053-45; 65862-053-90; 65862-053-01; 65862-053-00; 65862-053-99; 65862-053-22; 65862-054-30; 65862-054-45; 65862-054-90; 65862-054-00; 65862-054-99; 65862-054-39 | Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B | Aurobindo Pharma USA Inc. / 2,352/1000 count bottles | Class III | Terminated |
| D-1825-2019 | 07-26-2019 | Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 66577 8. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 1,872,984 bottles | Class II | Terminated |
| D-1824-2019 | 07-26-2019 | Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 65920 3. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 927,108 bottles | Class II | Terminated |
| D-1830-2019 | 07-26-2019 | Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 30; Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 10678112106995. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 1,752 bottles | Class II | Terminated |
| D-1831-2019 | 07-26-2019 | Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 17,316 bottles | Class II | Terminated |
| D-1834-2019 | 07-26-2019 | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distributed by Select Corporation, Carrolton, TX 75007; Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 55708 01039 6. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 1,030,128 bottles | Class II | Terminated |
| D-1829-2019 | 07-26-2019 | Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (individual bottle UPC 6 78112 25415 6); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 124,038 bottles | Class II | Terminated |
| D-1833-2019 | 07-26-2019 | Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591; A Prestige Brands Company. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 793,872 bottles | Class II | Terminated |
| D-1826-2019 | 07-26-2019 | Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 66577 8); and c) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 65920 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, display UPC 6 78112 10452 9. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 20,808 bottles | Class II | Terminated |
| D-1832-2019 | 07-26-2019 | Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 3), Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 1,836 bottles | Class II | Terminated |
| D-1822-2019 | 07-26-2019 | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4); c) 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591; A Prestige Brands Company. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 6,661,188 bottles | Class II | Terminated |
| D-1835-2019 | 07-26-2019 | Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591 A Prestige Brands Company. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 314,112 bottles | Class II | Terminated |
| D-1828-2019 | 07-26-2019 | Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 66577 8); and c) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 65920 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 00678112106905. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 25,992 bottles | Class II | Terminated |
| D-1827-2019 | 07-26-2019 | Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); and b) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 00678112105434. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 66,168 bottles | Class II | Terminated |
| D-1823-2019 | 07-26-2019 | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. by Lil' Drug Store Products Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402; Medtech Products Inc., Tarrytown, NY 10591, UPC 7 92554 70103 7. | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products. | Medtech Products, Inc. / 1,621,200 bottles | Class II | Terminated |
| D-0027-2020 | 07-24-2019 | C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 vial | Class II | Terminated |
| D-0033-2020 | 07-24-2019 | C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 7 vials | Class II | Terminated |
| D-0018-2020 | 07-24-2019 | C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 191 syringes | Class II | Terminated |
| D-0015-2020 | 07-24-2019 | C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 droptainer bottle | Class II | Terminated |
| D-0028-2020 | 07-24-2019 | C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 vial | Class II | Terminated |
| D-0009-2020 | 07-24-2019 | C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 37 vials | Class II | Terminated |
| D-0023-2020 | 07-24-2019 | C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 vial | Class II | Terminated |
| D-0021-2020 | 07-24-2019 | C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 2 vials | Class II | Terminated |
| D-0019-2020 | 07-24-2019 | C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 6 vials | Class II | Terminated |
| D-0017-2020 | 07-24-2019 | C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 15 syringes | Class II | Terminated |
| D-0013-2020 | 07-24-2019 | C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 15 syringes | Class II | Terminated |
| D-0030-2020 | 07-24-2019 | C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 vial | Class II | Terminated |
| D-0031-2020 | 07-24-2019 | C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 vial | Class II | Terminated |
| D-0016-2020 | 07-24-2019 | C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 6 syringes | Class II | Terminated |
| D-0014-2020 | 07-24-2019 | C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 18 vials | Class II | Terminated |
| D-0011-2020 | 07-24-2019 | C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 vial | Class II | Terminated |
| D-0005-2020 | 07-24-2019 | C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 12 droptainer bottles | Class II | Terminated |
| D-0026-2020 | 07-24-2019 | C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 vial | Class II | Terminated |
| D-0008-2020 | 07-24-2019 | C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 60 nebulizer vials | Class II | Terminated |
| D-0010-2020 | 07-24-2019 | C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 droptainer vial | Class II | Terminated |
| D-0007-2020 | 07-24-2019 | C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 vial | Class II | Terminated |
| D-0032-2020 | 07-24-2019 | C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 droptainer bottle | Class II | Terminated |
| D-0022-2020 | 07-24-2019 | C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 vial | Class II | Terminated |
| D-0034-2020 | 07-24-2019 | C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 vial | Class II | Terminated |
| D-0025-2020 | 07-24-2019 | C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 vial | Class II | Terminated |
| D-0024-2020 | 07-24-2019 | C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 7 vials | Class II | Terminated |
| D-0020-2020 | 07-24-2019 | C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 vial | Class II | Terminated |
| D-0006-2020 | 07-24-2019 | C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 droptainer bottles | Class II | Terminated |
| D-0003-2020 | 07-24-2019 | C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 2 droptainer bottles | Class II | Terminated |
| D-0029-2020 | 07-24-2019 | C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 vial | Class II | Terminated |
| D-0012-2020 | 07-24-2019 | C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 30 syringe | Class II | Terminated |
| D-0004-2020 | 07-24-2019 | C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy / 1 droptainer bottle | Class II | Terminated |
| D-1722-2019 | 07-24-2019 | Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01 Package NDCs: 47781-303-01 | Failed dissolution specifications | Alvogen, Inc / 2784 bottles | Class II | Terminated |
| D-1723-2019 | 07-24-2019 | Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01 Package NDCs: 52427-285-01 | Failed dissolution specifications | Alvogen, Inc / 4272 bottles | Class II | Terminated |
| D-1586-2019 | 07-23-2019 | Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Package NDCs: 68462-192-17; 68462-192-55 | GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty. | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Terminated |
| D-1568-2019 | 07-22-2019 | Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. | Lack of Processing Controls | Wise Pharmacy / 4 vials | Class II | Terminated |
| D-1572-2019 | 07-22-2019 | Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. | Lack of Processing Controls | Wise Pharmacy / 8 vials | Class II | Terminated |
| D-1567-2019 | 07-22-2019 | Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123. | Lack of Processing Controls | Wise Pharmacy / 1 bottle | Class II | Terminated |
| D-1571-2019 | 07-22-2019 | Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. | Lack of Processing Controls | Wise Pharmacy / 1 container | Class II | Terminated |
| D-1570-2019 | 07-22-2019 | Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. | Lack of Processing Controls | Wise Pharmacy / 1 container | Class II | Terminated |
| D-1569-2019 | 07-22-2019 | Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. | Lack of Processing Controls | Wise Pharmacy / 27 vials | Class II | Terminated |
| D-1574-2019 | 07-22-2019 | Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. | Lack of Processing Controls | Wise Pharmacy / 44 vials | Class II | Terminated |
| D-1576-2019 | 07-22-2019 | Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. | Lack of Processing Controls | Wise Pharmacy / 32 vials | Class II | Terminated |
| D-1573-2019 | 07-22-2019 | Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. | Lack of Processing Controls | Wise Pharmacy / 84 vials | Class II | Terminated |
| D-1575-2019 | 07-22-2019 | Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. | Lack of Processing Controls | Wise Pharmacy / 97 vials | Class II | Terminated |
| D-1577-2019 | 07-22-2019 | Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. | Lack of Processing Controls | Wise Pharmacy / 14 vials | Class II | Terminated |
| D-1528-2019 | 07-19-2019 | MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8. | Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content. | Dercher Enterprises, Inc., DBA Gordon Laboratories / 277 boxes | Class II | Terminated |
| D-1515-2019 | 07-19-2019 | Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ | Failed Dissolution Specifications | Ascend Laboratories LLC / a) 5,472 bottles and b) 5,880 bottles | Class II | Terminated |
| D-1581-2019 | 07-19-2019 | Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02 Package NDCs: 68180-518-02; 68180-518-01; 68180-518-30; 68180-519-30; 68180-519-01; 68180-519-02; 68180-520-02; 68180-520-30; 68180-520-01 | Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle. | Lupin Pharmaceuticals Inc. / 11,832 bottles | Class II | Terminated |
| D-1838-2019 | 07-18-2019 | Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66. Package NDCs: 50474-594-40; 50474-595-40; 50474-596-40; 50474-597-66; 50474-001-48 | Failed Dissolution Specifications. | Ucb, Inc / 2088 bottles | Class II | Terminated |
| D-1514-2019 | 07-18-2019 | 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38. Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Lack of Assurance of Sterility: Bags have potential to leak. | Baxter Healthcare Corporation / 139,680 Containers | Class II | Terminated |
| D-1516-2019 | 07-18-2019 | Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08) | Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets | Amneal Pharmaceuticals, Inc. / a) 2,256 bottles; b) 240 bottles | Class III | Terminated |
| D-1491-2019 | 07-18-2019 | Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Generic for: Maxitrol, For External Use Only, Rx only, Mfg: Paddock Laboratories, LLC, Preferred Pharmaceuticals, Inc., The Physicians Solutions, Anaheim, CA, NDC 68788-9373-03. | CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility. | Preferred Pharmaceuticals, Inc / 171 tubes | Class II | Terminated |
| D-1579-2019 | 07-17-2019 | Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979 | Subpotent Drug | ImprimisRx NJ / 246 bottles | Class II | Terminated |
| D-1578-2019 | 07-17-2019 | Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979 | Subpotent Drug | ImprimisRx NJ / 405 bottles | Class II | Terminated |
| D-1844-2019 | 07-17-2019 | Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 count (NDC 33342-159-44) bottles, Manufactured : Macleods Pharma USA, Inc Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himchal Pradesh, INDIA Package NDCs: 33342-159-07; 33342-159-11; 33342-159-44; 33342-159-12; 33342-159-15 | Failed Dissolution Specifications | Macleods Pharma Usa Inc / a) 5448 bottles b) 972 bottles c) 158 bottles | Class II | Terminated |
| D-1720-2019 | 07-17-2019 | Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-01 Package NDCs: 68180-518-02; 68180-518-01; 68180-518-30; 68180-519-30; 68180-519-01; 68180-519-02; 68180-520-02; 68180-520-30; 68180-520-01 | Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles. | Lupin Pharmaceuticals Inc. / 39,216 bottles | Class II | Terminated |
| D-1518-2019 | 07-17-2019 | Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01 Package NDCs: 68180-545-02; 68180-545-03; 68180-545-01 | Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation. | Lupin Pharmaceuticals Inc. / 33,939 tubes | Class III | Terminated |
| D-1508-2019 | 07-16-2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-537-07; 67877-537-14; 67877-538-07; 67877-538-14; 67877-539-07; 67877-539-14; 67877-540-07; 67877-540-14; 67877-541-07; 67877-541-14; 67877-542-07 | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. | Deva Holding AS - Cerkezkoy Subesi / a) 5736 bottles; b) 8460 bottles | Class II | Terminated |
| D-1510-2019 | 07-16-2019 | Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-537-07; 67877-537-14; 67877-538-07; 67877-538-14; 67877-539-07; 67877-539-14; 67877-540-07; 67877-540-14; 67877-541-07; 67877-541-14; 67877-542-07 | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. | Deva Holding AS - Cerkezkoy Subesi / a) 13752 bottles; b) 15696 bottles | Class II | Terminated |
| D-1511-2019 | 07-16-2019 | Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-537-07; 67877-537-14; 67877-538-07; 67877-538-14; 67877-539-07; 67877-539-14; 67877-540-07; 67877-540-14; 67877-541-07; 67877-541-14; 67877-542-07 | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. | Deva Holding AS - Cerkezkoy Subesi / a) 7380 bottles; b) 10332 bottles | Class II | Terminated |
| D-1512-2019 | 07-16-2019 | Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-537-07; 67877-537-14; 67877-538-07; 67877-538-14; 67877-539-07; 67877-539-14; 67877-540-07; 67877-540-14; 67877-541-07; 67877-541-14; 67877-542-07 | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. | Deva Holding AS - Cerkezkoy Subesi / a) 5052 bottles; b) 3816 bottles | Class II | Terminated |
| D-1513-2019 | 07-16-2019 | Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-542-07. Package NDCs: 67877-537-07; 67877-537-14; 67877-538-07; 67877-538-14; 67877-539-07; 67877-539-14; 67877-540-07; 67877-540-14; 67877-541-07; 67877-541-14; 67877-542-07 | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. | Deva Holding AS - Cerkezkoy Subesi / 11472 bottles | Class II | Terminated |
| D-1519-2019 | 07-16-2019 | Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45. Package NDCs: 69452-116-45 | Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed. | Bionpharma Inc. / 3,020 bottles | Class II | Terminated |
| D-1509-2019 | 07-16-2019 | Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-537-07; 67877-537-14; 67877-538-07; 67877-538-14; 67877-539-07; 67877-539-14; 67877-540-07; 67877-540-14; 67877-541-07; 67877-541-14; 67877-542-07 | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. | Deva Holding AS - Cerkezkoy Subesi / a) 11376 bottles; b) 13620 bottles | Class II | Terminated |
| D-1632-2019 | 07-15-2019 | DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302255010 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 432 cartons | Class II | Terminated |
| D-1633-2019 | 07-15-2019 | CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-use vials per Carton,0.05 fl. oz. (1.5 mL) each 1.5 fl. oz. (45 mL) total, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 48 cartons | Class II | Terminated |
| D-1566-2019 | 07-15-2019 | LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft & moisturizing featuring titanium dioxide, 1 wipe individually wrapped packet, 4.75" x 5.75" (12.0 cm x 14.6 cm) Ingredients: Water, Dimethicone, Dimethiconol, Titanium Dioxide, Benzophenone-3, Octinoxate, Ethylhexylglycerine, Phenoxyethanol, Distributed by La Fresh Group, Inc. Chino, CA 91710 www.LaFreshGroup.com | Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites. | La Fresh Group, Inc. / 83,050 packets | Class II | Terminated |
| D-1631-2019 | 07-15-2019 | CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 69842-261-01 UPC 050428597156 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 48 cartons | Class II | Terminated |
| D-1590-2019 | 07-12-2019 | Baby Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1627-2019 | 07-12-2019 | Anemia Off, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1616-2019 | 07-12-2019 | Stomach Flu Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1622-2019 | 07-12-2019 | Detensin, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1598-2019 | 07-12-2019 | Glauco-Catar Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1626-2019 | 07-12-2019 | Appetrol Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1625-2019 | 07-12-2019 | Mental Tonic Capsules, Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1600-2019 | 07-12-2019 | Herpes-G Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1587-2019 | 07-12-2019 | Asma Aid Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1623-2019 | 07-12-2019 | Smoke End Capsules,Distributed Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1617-2019 | 07-12-2019 | Stone Purger Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1607-2019 | 07-12-2019 | Lung Fixer Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1609-2019 | 07-12-2019 | Lung Tonic EX Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1628-2019 | 07-12-2019 | Asma Stopper Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1599-2019 | 07-12-2019 | Hair Back, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
