Guaifenesin DAC Oral Solution — Class II drug recall D-1364-2019
Terminated recall by Torrent Pharma Inc, reported 2019-06-19, distributed nationwide. cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii
| Recall number | D-1364-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Torrent Pharma Inc, Levittown, PA, United States |
| Recall initiated | 2019-05-21 |
| Classified | 2019-06-13 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2020-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 6,000 bottles |
| Reason classes | cgmp |
| Pathogens | burkholderia |
| NDC | 16571-0301-16 |
| Lot numbers | 17E031, 18F030 |
| Expiration dates | 2019-05, 2020-06 |
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.
Reason for recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1364-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.