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Recall 2016-114: Teva - Amikacin Sulf Inj - NYC - Consumer


URGENT!!!            DRUG RECALL!!!            URGENT!!!

NDC                     Label Name                                                Lots             Expiration
00703903203       AMIKACIN SULF 500 MG/2 ML VIAL        7080315      03/31/17
00703903203       AMIKACIN SULF 500 MG/2 ML VIAL        7400315      03/31/17
00703903203       AMIKACIN SULF 500 MG/2 ML VIAL        7410315      03/31/17
00703903203       AMIKACIN SULF 500 MG/2 ML VIAL        7980415      04/30/17
00703904003       AMIKACIN SULF 1GM/4 ML VIAL             2381114      11/30/16
00703904003       AMIKACIN SULF 1GM/4 ML VIAL             2771114      11/30/16
00703904003       AMIKACIN SULF 1GM/4 ML VIAL             4760915      09/30/17

Teva Pharmaceuticals is voluntarily recalling the above item(s)/lot(s) due to the potential for the presence of glass particulate matter. This recall is to the Consumer level. Affected product started shipping July 10, 2015.

Serious health consequences may arise from the inadvertent administration of glass particles.

For medical related questions please contact Teva Medical Information at 888-838-2872, option 3, then, option 4. Consumers should immediately contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

Adverse reactions experienced with the use of this product may be reported to Teva Pharmaceuticals at 1-888-838-2872, option 3, then option 4. Adverse Events or product quality issues experienced with this product can also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Contact:

Inmar: Inmar Customer Service 877-208-2407