Manufacturer profile
Atlantis Consumer Healthcare, Inc.
Pharmaceutical company4 products tracked
4
products tracked
21,361
total reports
68
recalls on record
75.9%
serious overall
Products
showing 4 of 4
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| — | 7,960 | Parophthalmia | 0 | |
| 1985 | 7,960 | Toxic anterior segment syndrome | 42 | |
| 1985 | 4,083 | Toxic anterior segment syndrome | 26 | |
| — | 1,358 | Febrile neutropenia | 0 |
Recall history · 33 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Jun 4, 2026 | II | sub potency | Elevate Oral Care |
| Aug 19, 2025 | III | Subpotent drug | Medline Industries, LP |
| Feb 13, 2025 | II | Defective Container: broken or leaking bottles. | World Perfumes Inc. |
| Sep 11, 2024 | II | Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000. | Zhejiang Jingwei Pharmaceutical Co., Ltd. |
| Oct 19, 2023 | II | CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements. | Safecor Health, LLC |
| Aug 9, 2023 | II | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Ecometics, Inc. |
| Dec 1, 2022 | I | Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL | BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Dec 6, 2021 | II | Lack of Assurance of Sterility | Edge Pharma, LLC |
| Aug 26, 2021 | II | Subpotent Drug | AVRIO HEALTH L.P |
| Jul 23, 2021 | II | SubPotent: Out of Specification | Professional Disposables International, Inc |
| Jul 23, 2021 | II | SubPotent: Out of Specification | Professional Disposables International, Inc |
| Jul 23, 2021 | II | SubPotent: Out of Specification | Professional Disposables International, Inc |
| Jul 23, 2021 | II | SubPotent: Out of Specification | Professional Disposables International, Inc |
| Jul 23, 2021 | II | SubPotent: Out of Specification | Professional Disposables International, Inc |
| Apr 12, 2021 | II | Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility | Edge Pharma, LLC |
| Sep 18, 2019 | II | Lack of sterility assurance. | Avella of Deer Valley, Inc. Store 38 |
| Sep 13, 2019 | II | Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector. | GUERBET LLC |
| Feb 15, 2018 | II | Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. | Medline Industries Inc |
| Oct 5, 2017 | II | Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum. | Purdue Pharma, LP |
| Sep 21, 2017 | II | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc |
| Aug 4, 2017 | II | Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label. | Degasa Sa De Cv |
| Aug 6, 2015 | II | Chemical contamination: Product may be contaminated with a toxic compound. | 3M Company - Health Care Business |
| May 15, 2015 | II | Labeling: incorrect or missing lot number and/or expiration date | Mallinckrodt, Inc. |
| Dec 20, 2013 | II | Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label. | Carefusion 2200 Inc |
| Dec 20, 2013 | II | Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label. | Carefusion 2200 Inc |
| Jun 21, 2013 | II | Presence of foreign substance: One lot of the product may contain black foreign particles | Bracco Diagnostics Inc |
| May 29, 2013 | II | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 21, 2012 | II | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
| May 21, 2012 | II | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
| May 21, 2012 | II | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
| May 21, 2012 | II | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
| May 21, 2012 | II | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from Atlantis Consumer Healthcare, Inc. are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.