Recall Z-2013-2011 ยท KMJ Lubricant, Patient
DeRoyal Processing Center
Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF 31-702, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA; (2) DeRoyal(R) Water Soluble Lubricant, 1 / Pack, Size: 2 oz Rx Only, REF 31-704, STERILE EO, Distributor: DeRoyal, 200 DeBusk Lane, Powell, TN 37849, USA; (3) DeRoyal(R) Lubricant, Size: 5 Gram, Rx
| Date | Apr 18, 2011 (initiated Feb 7, 2011) |
| Status | Terminated |
| Reason | Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP deficiencies. |
| Root cause | Process control |
| Action | The firm notified their consignees by a Re: DeRoyal Recall Of Triad Group Lubricating Jelly letter, dated Friday, March 18,2011. The letter discussed the reason for recall and the affected products. The letter asked customers to identify inventory using the attached spreadsheet and quarantine to prevent further use. Customers are to complete the spreadsheet regardless if they have effected product or not. The completed form can be faxed to 865-362-3716 or emailed to recalls@deroyal.com. All affected products should be return to DeRoyal at the address provided. Distributors are to forwar |
| Quantity | 323,440 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K871169 | LUBRICATING JELLY H & P Industries, Inc., Apr 1, 1987 |