Why it was recalled
Lack of Assurance of Sterility: There are also CGMP Deviations.
Product description
LACTIC ACID SOLUTION in all strengths including 20%, 30%, and 60%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0549-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 10, 2017
- FDA report date
- Mar 22, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Synergy Rx
Original FDA data
Every field from FDA enforcement report D-0549-2017, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 76472
- Address
- 4901 Morena Blvd Ste 504A
- Code information
- All Lots
- Postal code
- 92117-7310
- Report date
- Mar 22, 2017
- Product type
- Drugs
- Recall number
- D-0549-2017
- Classification
- Class II
- Recalling firm
- Synergy Rx
- Termination date
- May 23, 2017
- Reason for recall
- Lack of Assurance of Sterility: There are also CGMP Deviations.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LACTIC ACID SOLUTION in all strengths including 20%, 30%, and 60%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 10, 2017
- Initial firm notification
- Telephone
- Center classification date
- Mar 15, 2017