Torrent Pharma Recalls Children's Acetaminophen Liquid Due to Potential Bacterial Contamination
Torrent Pharma Inc is recalling 58,272 bottles of Children's Acetaminophen Liquid 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 FDA classified this as a Class II recall involving potential contamination with specific bacterial pathogens (Burkholderia cepacia and Ralstonia pickettii), which fits the rubric criteria for Severe severity due to the risk of significant injury or adverse health consequences.
Plain-English summary
Torrent Pharma Inc is recalling 58,272 bottles of Children's Acetaminophen Liquid, 160 mg per 5 mL, Cherry Flavor, 4 FL. oz. (118 mL) bottles. The product is identified by NDC 59741-101-06, Lot # 17E035, and an expiration date of 05/2019. The bottles were manufactured by Bio-Pharm, Inc., in Levittown, PA.
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 FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
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 this specific lot and expiration date. If found, they should stop using the product and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL) bottle, NDC: 59741-101-06, Manufactured by Bio-Pharm, Inc., Levittown PA 19057, Assured.
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Liquid OTC Analgesic
- Affected units
- 58,272
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 (2)
- Lot #: 17E035
- Exp. 05/2019
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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