Teva Recalls Metoclopramide Injection Due to Chemical Contamination
Teva Pharmaceuticals is recalling Metoclopramide Injection vials due to an unknown brown residue found inside one vial.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves an unknown chemical contamination in a prescription drug, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Teva Pharmaceuticals USA is recalling 9,452 cartons of Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials. The recall is due to a chemical contamination issue where an unknown brown residue was found adhering to the inside of one vial.
The affected product is identified by Lot # 31325335B with an expiration date of 07/2021. The product was distributed nationwide, including Puerto Rico. The NDC numbers for the affected vials are 0703-4502-01 and 0703-4502-04.
Healthcare providers and patients should discontinue use of the affected lot and contact Teva Pharmaceuticals for further instructions or a replacement.
The recalled product
- Product
- METOCLOPRAMIDE (METOCLOPRAMIDE)
- Brand
- METOCLOPRAMIDE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 9,452
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 # 31325335B
- exp. date 07/2021
Distribution
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