Torrent Pharma Recalls Guaifenesin DAC Oral Solution Due to Contamination
Torrent Pharma Inc. is recalling specific lots of Guaifenesin DAC Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
What this means for you
Illness, injury, or structural failure has been reported. 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 specific bacterial pathogens, which aligns with the rubric criteria for Severe severity involving significant health risks.
Plain-English summary
Torrent Pharma Inc. is recalling 6,000 bottles of Guaifenesin DAC Oral Solution, Sugar free, 100 mg/30 mg/10 mg per 5 mL. The affected product is identified by NDC 16571-301-16 and includes Lot #17E031 (Exp. 05/2019) and Lot #18F030 (Exp. 06/2020). The product was manufactured by Bio-Pharm Inc. and distributed by Rising Pharmaceuticals Inc.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations that resulted in potential product contamination with Burkholderia cepacia and Ralstonia pickettii. The agency has classified this recall as Class II.
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 medication for the specific lot numbers and expiration dates listed above and discontinue use if they match the recalled product.
The recalled product
- Product
- Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongestant, Cough Suppressant, 100 mg/30 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-301-16, Manufactured by Bio-Pharm Inc., L
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 6,000
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 (4)
- Lot #s: 17E031
- Exp. 05/2019
- 18F030
- Exp. 06/2020.
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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