Torrent Pharma Recalls Hydrocodone and Homatropine Oral Solution Due to 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 recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the presence of specific bacterial contamination in a pharmaceutical product aligns with the higher severity criteria for Class II recalls involving significant health risks.
Plain-English summary
Torrent Pharma Inc. is recalling 7,728 bottles of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, 16 FL. oz. (473 mL) bottles. The recall is 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 affected product is identified by NDC 13668-577-10. The specific lots subject to recall are Lot #18E034 with an expiration date of 05/2020, and Lot #19A015 with an expiration date of 01/2021. 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 these specific lot numbers and expiration dates. If the product is found, it should be returned to the distributor or pharmacy for credit. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this medication.
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:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 7,728
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 (4)
- Lot #s: 18E034
- Exp. 05/2020
- 19A015
- Exp. 01/2021.
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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