Torrent Pharma Recalls Guaifenesin AC Cough Syrup Due to Bacterial Contamination
Torrent Pharma Inc. is recalling specific lots of Guaifenesin AC Cough Syrup 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, which corresponds to a Severe rating under the rubric for potential contamination with specific bacterial pathogens.
Plain-English summary
Torrent Pharma Inc. is recalling 233,388 bottles of Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16. The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations that resulted in potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii).
The affected product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States. The recall covers specific lot numbers with expiration dates ranging from August 2019 to May 2020, including lots 17H002, 17H005, 17H006, 17H007, 17H026, 17H027, 17J010, 17J013, 17K014, 17K015, 17L015, 17M026, 18A028, 18A031, 18B026, and 18E003.
Consumers should check their medication bottles for the NDC 16571-302-16 and the specific lot numbers and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 233,388
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: 17H002
- 17H005
- 17H006
- 17H007
- 17H026
- 17H027
- Exp. 08/2019
- 17J010
- 17J013
- Exp. 09/2019
- 17K014
- 17K015
- Exp. 10/2019
- 17L015
- Exp. 11/2019
- 17M026
- Exp. 12/2019
- 18A028
- 18A031
- Exp. 01/2020
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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