CLASS II Drug recall · Reported 29 Nov 2017 · FDA Enforcement Report
Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%) Gel recalled
Ridge Properties is recalling Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%) Gel (. The recall was initiated on 3 Nov 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0087-2018
- FDA event ID
- 78462
- Recalling firm
- Ridge Properties, Salem, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Nov 2017
- FDA classified
- 21 Nov 2017
- Reported
- 29 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Processing Deviation
- Drug class
- Pain Medication
Timeline
| 3 Nov 2017 | Recall initiated by company | |
| 21 Nov 2017 | Classified by FDA | +18 days |
| 29 Nov 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GMP Deviations: inadequate manufacturing control processes
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 69804-018-11), and 4 oz Gel (NDC 69804-018-12) jars, Manufactured by Pain Relief Naturally, www.Naturally HL.com
Where it was distributed
Product distributed throughout United States.
Stores named: Walmart
Questions about this recall
Is Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%) Gel ( recalled?
Yes. Ridge Properties recalled Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%) Gel ( on 3 Nov 2017. The recall is Class II and its status is Terminated. Recall number D-0087-2018.
Why was it recalled?
GMP Deviations: inadequate manufacturing control processes
Which lots are affected?
All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers
Where was it sold?
Product distributed throughout United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ridge Properties
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|---|---|---|---|---|---|
| Drug | CLASS II | Superior Pain & Itch Relief (lidocaine) Cream recalled | Ridge Properties | Potency & Assay | Nationwide |
| Drug | CLASS II | Soothing Sore Relief (lidocaine) Cream recalled by Ridge Properties | Ridge Properties | Potency & Assay | Nationwide |
| Drug | CLASS II | Soothing Sore Relief (lidocaine) Liquid Gel recalled by Ridge Properties | Ridge Properties | Potency & Assay | Nationwide |
| Drug | CLASS II | Pre-tat (lidocaine) 1 Pre Tattoo Prep With Lidocaine Cream recalled | Ridge Properties | Sterility | Nationwide |
| Drug | CLASS II | Superior Pain & Itch Relief (lidocaine) Liquid Gel recalled | Ridge Properties | Potency & Assay | Nationwide |