Torrent Pharma Recalls Memantine Hydrochloride Oral Solution Due to Contamination Risk
Torrent Pharma Inc. is recalling 264 bottles of Memantine Hydrochloride Oral 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 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 injury risks or Class II classifications with reported issues.
Plain-English summary
Torrent Pharma Inc. is recalling 264 bottles of Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz. bottles (NDC: 13668-573-09). The product was manufactured by Bio-Pharm Inc. in Levittown, PA, for Torrent Pharma Inc. in Basking Ridge, NJ. The specific lot number is 18F026, with an expiration date of 06/2020.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations that created a potential for product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). The agency has classified this as a Class II recall.
The product was distributed to 9 distributors, direct accounts, and relabelers, who may have further distributed the product throughout the United States. Patients and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or distributor for disposal or replacement.
The recalled product
- Product
- Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured By Bio-Pharm Inc., Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 264
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 #: 18F026
- 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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