CLASS II Drug recall · Reported 21 Sep 2022 · FDA Enforcement Report
Triamcinolone Acetonide cream, 1% tube recalled by Direct Rx
Direct Rx is recalling Triamcinolone Acetonide cream, 1% tube, distributed in Georgia, Idaho. The recall was initiated on 12 Sep 2022 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-1535-2022
- FDA event ID
- 90869
- Recalling firm
- Direct Rx, Dawsonville, GA
- Manufacturer
- Direct Rx
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 12 Sep 2022
- FDA classified
- 15 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 12 Sep 2022 | Recall initiated by company | |
| 15 Sep 2022 | Classified by FDA | +3 days |
| 21 Sep 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Product as listed by the FDA
Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.
Where it was distributed
Physicians and Medical Facilities in GA and ID
Questions about this recall
Is Triamcinolone Acetonide cream, 1% tube recalled?
Yes. Direct Rx recalled Triamcinolone Acetonide cream, 1% tube on 12 Sep 2022. The recall is Class II and its status is Completed. Recall number D-1535-2022.
Why was it recalled?
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Which lots are affected?
Lot: 12JY2216, Exp. 2/29/24
Where was it sold?
Physicians and Medical Facilities in GA and ID
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.
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