Z-2013-2011

Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF...

Name: Z-2013-2011 Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF...
Creator: DeRoyal Processing Center
Published: 2011-02-07
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2011-02-07 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Processing Center began a recall of 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... on 2011-02-07. The reason FDA records is "Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP deficiencies". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2013-2011
Status: Terminated
Initiated: 2011-02-07
Posted: 2011-04-18
Terminated: 2014-08-05
Recalling firm: DeRoyal Industries, Inc.
Product: 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 Only, REF 31-938, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA Lubricating body orifices.
Product code: KMJ Lubricant, Patient
Reason for recall: Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP deficiencies.
Root cause tag: manufacturing process
FDA 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 [email protected]. All affected products should be return to DeRoyal at the address provided. Distributors are to forward a copy of the notice to their end-users. If there are questions or assistance is needed with the recall, Stephanie DeBusk should be contacted at 865-362-1037 or Sharon Cook at 865-362-6157.
Quantity in commerce: 323,440 units
Distribution: Nationwide Distribution
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Product code KMJ

K871169Class ILubricating JellyH & P Industries, Inc. / cleared 1987-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)