Reported Jun 19, 2019 · Terminated
Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma,…
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?
Hyoscyamine Oral Drops 0.125 mg/mLRx Only15 mL bottle (0.5 FL. oz.)
- NDC
39328-047-15Manuf. for Patrin PharmaSkokie IL 60076
- Lot codes and dates
Lot #s: 17E039Exp. 05/201917K016Exp. 10/201918E021Exp. 05/202018G008Exp. 07/2020
- Amount recalled
- 53,520 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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