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 recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization reports are rated as Severe (4).
Plain-English summary
Torrent Pharma Inc. is recalling Risperidone Oral Solution, USP, 1 mg/mL, 30 mL bottles (NDC 13668-589-06) due to potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). The recall involves 48,955 bottles manufactured by Bio-Pharm Inc. for Torrent Pharma Inc.
The affected lots are 18F020, 18H013, 18J015, 18K015, 18K034, and 19A014, with expiration dates ranging from June 2020 to January 2021. The product was distributed to nine distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 48,955
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 (11)
- Lot #s: 18F020
- Exp. 06/2020
- 18H013
- Exp. 08/2020
- 18J015
- Exp. 09/2020
- 18K015
- 18K034
- Exp. 10/2020
- 19A014
- 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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