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Class II: temporary or reversible health riskTerminated

Teva Pharmaceuticals Amikacin Sulfate Injection Recall

Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hunga…

Teva Pharmaceuticals USA · North Wales, PA

Risk level
Class II
Reported by FDA
Oct 19, 2016
Recall ID
D-0023-2017
Check your lot numberHow we source this data

Summary

Teva Pharmaceuticals recalled Amikacin Sulfate Injection starting Jul 29, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0023-2017 on Oct 19, 2016. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).

Lot numbers, UPCs & expiration codes

Lot # 7080315, 7400315, 7410315, 7980415

Where it was sold

Nationwide and Puerto Rico

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0023-2017
Classification
Class II
Status
Terminated
Recall initiated
Jul 29, 2016
FDA report date
Oct 19, 2016
Quantity
27,547 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Teva Pharmaceuticals USA

Original FDA data

Every field from FDA enforcement report D-0023-2017, exactly as published.

Show all FDA fields
City
North Wales
State
PA
Status
Terminated
Country
United States
Event ID
74816
Address
1090 Horsham Rd
Code information
Lot # 7080315, 7400315, 7410315, 7980415
Postal code
19454-1505
Report date
Oct 19, 2016
Product type
Drugs
Recall number
D-0023-2017
Classification
Class II
Recalling firm
Teva Pharmaceuticals USA
Product quantity
27,547 vials
Termination date
Feb 5, 2018
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Jul 29, 2016
Initial firm notification
Letter
Center classification date
Oct 12, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0023-2017, published Oct 19, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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