FDAFDA · Food and drugs·Recall number D-1384-2019
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.
Published June 19, 2019 · Recall initiated: May 21, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Torrent Pharma Inc
- Distributor
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
- Lot
- Lot #s: 18E034, Exp. 05/2020; 19A015, Exp. 01/2021.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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