Torrent Pharma Recalls Allergy Liquid Antihistamine Due to Bacterial Contamination
Torrent Pharma Inc. is recalling 118,080 bottles of Allergy Liquid Antihistamine 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 specific bacterial pathogens, which meets the rubric criteria for a Severe rating.
Plain-English summary
Torrent Pharma Inc. is recalling 118,080 bottles of Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL, Alcohol free, 4 FL. oz. (118 mL) bottle. The product is identified by NDC 59741-119-06 and was manufactured by Bio-Pharm Inc. in Levittown, PA. The recall involves Lot #s 17E019 and 17E045, with an expiration date of 05/2019.
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.
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 stop using the product if it matches the recalled items.
The recalled product
- Product
- Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 4 FL. oz. (118 mL) bottle, NDC: 59741-119-06, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Assured.
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Liquid Antihistamine
- Hazard
- Affected units
- 118,080
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 (3)
- Lot #s: 17E019
- 17E045
- 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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