Why it was recalled
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Product description
SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 .
Lot numbers, UPCs & expiration codes
EXP MAY/2021
Where it was sold
Texas
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-0102-2021
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Sep 24, 2020
- FDA report date
- Dec 2, 2020
- Quantity
- 1392 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AA PRODUCTS INC
Original FDA data
Every field from FDA enforcement report D-0102-2021, exactly as published.
Show all FDA fields
- City
- Laredo
- State
- TX
- Status
- Completed
- Country
- United States
- Event ID
- 86497
- Address
- 8424 Amparan Rd
- Code information
- EXP MAY/2021
- Postal code
- 78045-1822
- Report date
- Dec 2, 2020
- Product type
- Drugs
- Recall number
- D-0102-2021
- Classification
- Class II
- Recalling firm
- AA PRODUCTS INC
- Product quantity
- 1392 bottles
- Reason for recall
- CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 .
- Distribution pattern
- Texas
- Recall initiation date
- Sep 24, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 23, 2020