Torrent Pharma Recalls Hydrocodone Oral Solution Due to Bacterial Contamination
Torrent Pharma Inc. is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall involving potential contamination with specific bacterial pathogens (Burkholderia cepacia and Ralstonia pickettii), which fits the rubric criteria for Severe severity (FDA Class II with significant health risk).
Plain-English summary
Torrent Pharma Inc. is recalling 11,112 bottles of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, 16 FL. oz. (473 mL) bottles. The affected product is identified by NDC 59741-262-16 and includes Lot #s 18B013 (Exp. 02/2020), 18E024, and 18E030 (Exp. 05/2020). The product was manufactured by Bio-Pharm Inc. in Levittown, PA.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations that resulted in potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or point of purchase for disposal or replacement in accordance with local regulations.
The recalled product
- 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: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA.
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 11,112
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #s: 18B013
- Exp. 02/2020
- 18E024
- 18E030
- Exp. 05/2020.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 41 recalled by Torrent Pharma Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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