Torrent Pharma Recalls Acetic Acid Otic Solution Due to Bacterial Contamination
Torrent Pharma is recalling specific lots of Acetic Acid Otic 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 FDA classified this as a Class II recall involving potential contamination with specific bacterial pathogens, which meets the rubric criteria for a Severe rating.
Plain-English summary
Torrent Pharma Inc. is recalling 14,016 bottles of Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL. The affected product is identified by NDC 64980-424-15 and includes Lot #s 18J005, 18J016, and 18J025, all with an expiration date of 09/2020. 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 (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 and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations.
The recalled product
- Product
- Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663.
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Ophthalmic/OTC
- Hazard
- Affected units
- 14,016
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: 18J005
- 18J016
- 18J025
- 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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