Recalls / Class II
Class IID-1384-2019
Product
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.
- Affected lot / code info
- Lot #s: 18E034, Exp. 05/2020; 19A015, Exp. 01/2021.
Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recalling firm
- Firm
- Torrent Pharma Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2091 Hartel Ave, N/A, Levittown, Pennsylvania 19057-4506
Distribution
- Quantity
- 7,728 bottles
- Distribution pattern
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Timeline
- Recall initiated
- 2019-05-21
- FDA classified
- 2019-06-13
- Posted by FDA
- 2019-06-19
- Terminated
- 2020-10-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1384-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.