The Recall Desk
ModerateFDA (Drugs)·D-1535-2022·Announced 2022-09-21

Triamcinolone Acetonide Cream Recalled Due to Manufacturing Quality Defects

Direct Rx is recalling Triamcinolone Acetonide cream 0.1% due to manufacturing quality deviations that resulted in gritty texture and lack of effectiveness. The affected lot is 12JY2216, expiring February 29, 2024.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The defect is a manufacturing quality control issue affecting product texture and effectiveness rather than inherent safety. Per the rubric, no harm has been reported and the hazard is quality-based rather than safety-based, warranting Score 2 (Moderate).

Plain-English summary

Direct Rx is recalling Triamcinolone Acetonide cream, 0.1%, in 80-gram tubes distributed to physicians and medical facilities in Georgia and Idaho. The affected lot number is 12JY2216, with an expiration date of February 29, 2024, and approximately 20 tubes are involved.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Product complaints reported that the cream has a gritty texture and lacks effectiveness, indicating manufacturing quality control failures.

The recalled product

Product
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE CREAM)
Brand
TRIAMCINOLONE ACETONIDE
Manufacturer
Direct Rx
Category
Drug
Hazard
  • manufacturing-defect
  • lack-of-effectiveness

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 12JY2216
  • Exp. 2/29/24

Distribution

Distributed in 2 states:

  • GA
  • ID

Related recalls

Same brand · TRIAMCINOLONE ACETONIDE

Same category