Reported Jun 19, 2019 · Terminated
Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP),…
Torrent Pharma Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Torrent Pharma Inc · 2091 Hartel Ave · Levittown, PA · 19057-4506
Is this the product you have?
- 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
- NDC16571-301-16, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Inc., Allendale, NJ 07401
- Lot codes and dates
Lot #s: 17E031Exp. 05/201918F030Exp. 06/2020
- Amount recalled
- 6,000 bottles
This recall covers 41 products
The agency filed one notice per product. You are reading one of them; the other 40 are below.
28 more are in the archive.
Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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