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Class IIDrug recallTerminated

GLYCOLIC ACID SOLUTION recall

Recalled by Synergy Rx of San Diego, CA · FDA report 03/22/2017

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class
Class II
Moderate
Status
Terminated
Closed 05/23/2017
Recall started
02/10/2017
Distribution
Nationwide

Reason for recall

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

Product
GLYCOLIC ACID SOLUTION, all strengths including 10%, 20%, 30%, 50%, and 60%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lot and code info
All Lots
Recall number
D-0540-2017
Event ID
76472
Initiated by
Voluntary: Firm initiated

Where it was distributed

Nationwide within the United States

  • Nationwide

Recall timeline

  1. 02/10/2017Firm started the recall
  2. 03/15/2017FDA classified it as Class II
  3. 03/22/2017Published in the FDA enforcement report
  4. 05/23/2017FDA closed (terminated) the recall

All products in this recall

81 products under event 76472

Frequently asked questions

Why was GLYCOLIC ACID SOLUTION recalled?
Lack of Assurance of Sterility: There are also CGMP Deviations.
What does Class II mean?
Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Where was the recalled product sold?
Nationwide within the United States
Is this recall still active?
The FDA lists the recall as terminated (closed 05/23/2017). FDA has determined the recall is complete and closed it.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 03/22/2017 · Do not rely on openFDA to make decisions regarding medical care