Torrent Pharma Recalls Pedia Relief Cough-Cold Oral Solution Due to Contamination
Torrent Pharma Inc is recalling Pedia Relief Cough-Cold 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 Burkholderia cepacia and Ralstonia pickettii represents a significant contamination risk that aligns with the 'Severe' criteria for significant injury reports or high-risk pathogens.
Plain-English summary
Torrent Pharma Inc is recalling 17,748 bottles of Pedia Relief Cough-Cold Oral Solution, a 4 Fl. oz. (118 mL) alcohol-free product containing chlorpheniramine maleate, dextromethorphan HBr, and pseudoephedrine HCl. The recall is due to 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 0904-5050-20 and includes lot numbers 17L020 (Exp. 11/2019), 18C025 (Exp. 03/2020), and 18J020 (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 medicine cabinets for these specific lot numbers and expiration dates. If found, they should stop using the product and contact their healthcare provider or the recalling firm for instructions on disposal or return.
The recalled product
- Product
- Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant, nasal decongestant, Chlorpheniramine Maleate, USP 2 mg; Dextromethorphan HBr, USP 10 mg; Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10 mL)), 4 Fl. oz. (118 mL) bottle, NDC:0904-5050-20…
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Oral Solution
- Affected units
- 17,748
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 (6)
- Lot #s: 17L020
- Exp. 11/2019
- 18C025
- Exp. 03/2020
- 18J020
- 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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