Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA…
Reason Lack of Assurance of Sterility
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of foreign tablets/capsules.
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Reason Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of…
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
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