Drug product
Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongestant, Cough Suppressant, 100 mg/30 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-301-16, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Inc., Allendale, NJ 07401.
D-1364-2019
Product summary
- Event
- Event 82889
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,000 bottles
- Official record key
drug-enforcement:D-1364-2019
Official wording
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Code information: Lot #s: 17E031, Exp. 05/2019; 18F030, Exp. 06/2020.
Distribution pattern: Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations
-
Microbial contamination
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia