Torrent Pharma Recalls Risperidone Oral Solution Due to Bacterial Contamination
Torrent Pharma Inc. is recalling Risperidone Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 aligns with the rubric criteria for Severe severity regarding significant injury risks or high-risk pathogens.
Plain-English summary
Torrent Pharma Inc. is recalling RisperiDONE Oral Solution, USP, 1 mg/mL, 30 mL bottles (NDC 23155-317-51). The recall involves 52,368 bottles manufactured for Heritage Pharmaceuticals Inc. The affected lots are 17F012, 17F012A, 17G031, 17H004, 17H031, 18B004, and 18C028, with expiration dates ranging from June 2019 to March 2020.
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. Patients and healthcare providers should stop using the affected lots and contact their healthcare provider for guidance on alternative treatment options.
The recalled product
- Product
- RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816.
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 52,368
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 (12)
- Lot #s: 17F012
- 17F012A
- Exp. 06/2019
- 17G031
- Exp. 07/2019
- 17H004
- 17H031
- Exp. 08/2019
- 18B004
- Exp. 02/2020
- 18C028
- Exp. 03/2020
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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