D-1363-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2019
- Initiation Date
- May 21, 2019
- Termination Date
- October 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 233,388 bottles
Product Description
Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663
Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Distribution Pattern
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Code Information
Lot #s: 17H002; 17H005; 17H006; 17H007; 17H026; 17H027, Exp. 08/2019; 17J010; 17J013, Exp. 09/2019; 17K014; 17K015, Exp. 10/2019; 17L015, Exp. 11/2019; 17M026, Exp. 12/2019; 18A028; 18A031, Exp. 01/2020; 18B026, Exp. 02/2020; 18E003, Exp. 05/2020.