Why it was recalled
cGMP deviations
Product description
Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380, Guadalajara, Jalisco, Mexico, Made in Mexico.
Lot numbers, UPCs & expiration codes
Lot # a) 0005295, Exp 4/2022, 0006373, Exp 5/2022; b 0005412, Exp 4/2022, 0007134, Exp 5/2022, 0007834, Exp 5/2022, 0009239, Exp 6/2022
Where it was sold
Nationwide United States and Canada.
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-1555-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 31, 2020
- FDA report date
- Sep 9, 2020
- Quantity
- 211,875 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Laboratorios Jaloma S.A. de C.V.
Original FDA data
Every field from FDA enforcement report D-1555-2020, exactly as published.
Show all FDA fields
- City
- Guadalajara
- Status
- Terminated
- Country
- Mexico
- Event ID
- 86167
- Address
- Calle Aquiles Serdan No. 438
- Address (line 2)
- Col. Oblatos, Guadalajara
- Code information
- Lot # a) 0005295, Exp 4/2022, 0006373, Exp 5/2022; b 0005412, Exp 4/2022, 0007134, Exp 5/2022, 0007834, Exp 5/2022, 0009239, Exp 6/2022
- Report date
- Sep 9, 2020
- Product type
- Drugs
- Recall number
- D-1555-2020
- Classification
- Class II
- Recalling firm
- Laboratorios Jaloma S.A. de C.V.
- Product quantity
- 211,875 bottles
- Termination date
- Aug 23, 2022
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380, Guadalajara, Jalisco, Mexico, Made in Mexico.
- Distribution pattern
- Nationwide United States and Canada.
- Recall initiation date
- Jul 31, 2020
- Initial firm notification
- Press Release
- Center classification date
- Aug 28, 2020