D-1304-2019 Class II Terminated
FDA drug recall D-1304-2019 was initiated by Unipharma, Llc. on May 2, 2019 and is designated Class II. Reason for recall: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. The recall status is terminated (terminated November 25, 2020). Affected quantity: 23712 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2019
- Initiation Date
- May 2, 2019
- Termination Date
- November 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23712 cartons
Product Description
CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
Reason for Recall
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Distribution Pattern
Nationwide and Venezuela
Code Information
Lots: 80026 Exp. 05/31/20; 80027 Exp. 07/31/20