Teva Recalls Metoclopramide Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of Metoclopramide Injection because there is a lack of assurance of sterility. The product was distributed nationwide.
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 risks such as sterility issues in injectable drugs are categorized as Severe (Score 4), particularly when hospitalization reports or significant injury risks are implied by the nature of the defect.
Plain-English summary
Teva Pharmaceuticals USA is recalling Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vials. The recall is due to a lack of assurance of sterility. The affected product is identified by Lot # 31325459B with an expiration date of 08/2021.
The product was distributed nationwide. It is a prescription-only medication manufactured by TEVA Parenteral Medicines, Inc. in Irvine, CA. The specific NDC for the recalled packaging is 0703-4502-04.
Healthcare providers and patients should check their inventory and medication vials for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should not be used. Patients should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- METOCLOPRAMIDE (METOCLOPRAMIDE)
- Brand
- METOCLOPRAMIDE
- Manufacturer
- Teva Pharmaceuticals USA
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 # 31325459B
- exp. date 08/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Teva Pharmaceuticals USA 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 5 products in this recall →Related recalls
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