Torrent Pharma Recalls Acetaminophen Oral Solution Due to Bacterial Contamination
Torrent Pharma is recalling Pain & Fever 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 presence of specific bacterial contaminants (Burkholderia cepacia and Ralstonia pickettii) in an oral solution represents a significant health risk, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.
Plain-English summary
Torrent Pharma Inc is recalling specific lots of Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored. The recall involves 1,883,796 bottles in 4 Fl. oz. and One Pint (473 mL) sizes, distributed by Rugby Laboratories.
The recall was initiated due to cGMP deviations that resulted in potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). The affected products were distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States.
Consumers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact Torrent Pharma Inc or their healthcare provider for further instructions.
The recalled product
- Product
- Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored, a) 4 Fl. oz. bottle, NDC: 0536-0122-97, b) One Pint (473 mL) bottle, NDC: 0536-0122-85, Distributed by Rugby Laboratories, Lavonia, MI 48152 USA.
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Oral Solution
- Affected units
- 1,883,796
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 (20)
- Lot #s: a) 17E022
- 17E037
- Exp. 05/2019
- 17G006
- 17G026
- Exp. 07/2019
- 17H019
- 17H020
- Exp. 08/2019
- 17J020
- Exp. 09/2019
- 17K006
- 17K012
- Exp. 10/2019
- 17L028
- 17L033
- Exp. 11/2019
- 18A001
- 18A006
- 18A013
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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