Metoclopramide Injection Vials Recalled for Lack of Sterility Assurance
Teva Pharmaceuticals USA is recalling 25,653 vials of Metoclopramide Injection USP due to lack of assurance of sterility. The affected vials were distributed nationwide, including Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. Lack of sterility assurance in injectable medications poses a significant risk of infection and harm, particularly in a parenteral route of administration. While no specific illnesses or hospitalizations are reported in the source text, the class designation and inherent risk of non-sterile injected products meet the Severe threshold.
Plain-English summary
Teva Pharmaceuticals USA is recalling Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) in 2 mL single-use vials. The recall affects 25,653 vials due to lack of assurance of sterility.
The affected product was distributed nationwide, including Puerto Rico. The recalled lot numbers are: 31326043B (expiration date 10/2021), 31326138B (expiration date 11/2021), 31329399B (expiration date 08/2023), 31329539B (expiration date 08/2023), and 31329599B (expiration date 09/2023). The NDC is 0703-4502-01.
Patients and healthcare providers who have this medication should not use the affected vials and should contact Teva Pharmaceuticals USA or consult with their healthcare provider regarding the recall.
The recalled product
- Product
- METOCLOPRAMIDE (METOCLOPRAMIDE)
- Brand
- METOCLOPRAMIDE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable / Parenteral
- Hazard
- sterility-assurance-failure
- infection-risk
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 (8)
- Lot #: 31326043B
- exp. date 10/2021
- 31326138B
- exp. date 11/2021 31329399B
- 31329539B
- exp. date 08/2023
- 31329599B
- exp. date 09/2023
Distribution
Distributed nationwide across the United States.
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