Torrent Pharma Recalls Memantine Hydrochloride Oral Solution Due to Contamination
Torrent Pharma Inc is recalling 5,681 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 FDA classifies this recall as Class II. Per the rubric, FDA Class II recalls involving potential contamination with specific pathogens are categorized as Severe (Score 4), particularly given the risk of adverse health consequences from bacterial contamination in an oral solution.
Plain-English summary
Torrent Pharma Inc is recalling 5,681 bottles of Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle (NDC: 39328-551-12). 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 includes specific lots with expiration dates ranging from May 2019 to December 2019.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Oral Solution
- Affected units
- 5,681
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 (13)
- Lot #s: 17E001
- Exp. 05/2019
- 17F014
- Exp. 06/2019
- 17G005
- 17G010
- Exp. 07/2019
- 17J019
- 17J021
- Exp. 09/2019
- 17M008
- 17M009
- Exp. 12/2019.
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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