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HR Lubricating Jelly
HR PHARMACEUTICALS INC. · Model 201 · UDI-DI 00851809002012
10
510(k) clearances
68
Adverse events
17
Recalls
114
Facilities
Description
Sterile Lubricating Jelly, Tube
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2016-12-12 | MEDLINE IND | Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company. |
| 2016-05-20 | Amerx Health Care Corp. | Product did not meet specifications for Zinc Acetate (OOS). |
| 2012-07-13 | Westone Laboratories, Inc. | Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product. |
| 2011-03-17 | Eli Lilly and Company | Eli Lilly and Company announced 3/17/2011 that patients should not use the alcohol prep pads made by the Triad Group that are contained in the black starter kits for Forteo [teripa |
| 2011-02-28 | Cardinal Health | The Presource kits were assembled with non-sterile petroleum base lubricant instead of the labeled sterile water base lubricating jelly. |
| 2011-02-24 | Teleflex Medical | The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, due to a potential bacterial contamination. |
| 2011-02-24 | Teleflex Medical | The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, due to a potential bacterial contamination. |
| 2011-02-07 | DeRoyal Processing Center | Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP deficiencies. |
| 2011-01-18 | Apogee Medical | This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.