Torrent Pharma Recalls Pseudoephedrine Oral Solution Due to Potential Bacterial Contamination
Torrent Pharma Inc is recalling Pseudoephedrine 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 involves potential contamination with Burkholderia cepacia, a pathogen associated with serious infections, meeting the criteria for a Severe rating.
Plain-English summary
Torrent Pharma Inc is recalling 1,436,904 bottles of Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant, One Pint (473 mL) bottle, NDC: 0536-1850-85. The product is distributed by Rugby Laboratories, Livonia MI 48152.
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 lots are 17H012 (Exp. 08/2019), 17L011 (Exp. 11/2019), 17M020 (Exp. 12/2019), 18D007 (Exp. 04/2020), and 18J001 (Exp. 09/2020).
The product was 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 above and discontinue use if found.
The recalled product
- Product
- Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant, One Pint (473 mL) bottle, NDC: 0536-1850-85, Distributed by Rugby Laboratories, Livonia MI 48152.
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Oral Solution
- Affected units
- 1,436,904
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 (10)
- Lot #s: 17H012
- Exp. 08/2019
- 17L011
- Exp. 11/2019
- 17M020
- Exp. 12/2019
- 18D007
- Exp. 04/2020
- 18J001
- Exp. 09/2020.
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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