Claris Recalls Metronidazole Injection Due to Sterility Concerns
Claris Lifesciences Inc. is recalling 72,072 units of Metronidazole Injection, USP, 500 mg/100 mL, due to a potential leak that may compromise sterility.
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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated as Severe (4). While no specific injuries are reported in the text, the potential for sterility breach in an injectable drug is a significant hazard.
Plain-English summary
Claris Lifesciences Inc. is recalling 72,072 units of Metronidazole Injection, USP, 500 mg/100 mL, Rx only. The product is manufactured for Claris Lifesciences Inc. in North Brunswick, NJ, by Claris Injectable Ltd. in Gujarat, India. The recall covers lots A060205 and A060209, which expire in January 2018.
The recall is being conducted because there is a potential for a leak from the primary container. This leak may result in a breach of sterility and contamination of the product. The agency has classified this recall as Class II.
The product was distributed nationwide. 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 the recalling firm.
The recalled product
- Product
- Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24
- Manufacturer
- Claris Lifesciences Inc
- Category
- Drug — Injectable
- Affected units
- 72,072
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 #: A060205
- A060209
- Exp.Jan 2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Claris Lifesciences 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.
See all 4 products in this recall →Related recalls
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