Why it was recalled
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Product description
DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321
Lot numbers, UPCs & expiration codes
Lot: 80003 Exp. 01/31/20; 70003 Exp. 10/31/19; 70005 Exp. 11/30/19; 70006 Exp. 11/30/19
Where it was sold
U.S.A. Nationwide
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-0133-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 23, 2019
- FDA report date
- Oct 16, 2019
- Quantity
- 456 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Unipharma, Llc.
Original FDA data
Every field from FDA enforcement report D-0133-2020, exactly as published.
Show all FDA fields
- City
- Tamarac
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 83881
- Address
- 10200 NW 67th St
- Code information
- Lot: 80003 Exp. 01/31/20; 70003 Exp. 10/31/19; 70005 Exp. 11/30/19; 70006 Exp. 11/30/19
- Postal code
- 33321-6404
- Report date
- Oct 16, 2019
- Product type
- Drugs
- Recall number
- D-0133-2020
- Classification
- Class II
- Recalling firm
- Unipharma, Llc.
- Product quantity
- 456 cartons
- Termination date
- Mar 23, 2021
- Reason for recall
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Sep 23, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2019