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Class II: temporary or reversible health riskTerminated

Teva Pharmaceuticals INDOMETHACIN Capsules Recall

INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count…

Teva Pharmaceuticals USA · Horsham, PA

Risk level
Class II
Reported by FDA
May 21, 2014
Recall ID
D-1295-2014
Check your lot numberHow we source this data

Summary

Teva Pharmaceuticals recalled INDOMETHACIN Capsules starting Mar 24, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1295-2014 on May 21, 2014. Reason: CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. Status: Terminated.

Why it was recalled

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.

Product description

INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960

Lot numbers, UPCs & expiration codes

TE38139, Exp. 08/16, TE39022, Exp. 09/16,

Where it was sold

Nationwide

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-1295-2014
Classification
Class II
Status
Terminated
Recall initiated
Mar 24, 2014
FDA report date
May 21, 2014
Quantity
5812 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Teva Pharmaceuticals USA

Original FDA data

Every field from FDA enforcement report D-1295-2014, exactly as published.

Show all FDA fields
City
Horsham
State
PA
Status
Terminated
Country
United States
Event ID
67811
Address
425 Privet Rd
Code information
TE38139, Exp. 08/16, TE39022, Exp. 09/16,
Postal code
19044-1220
Report date
May 21, 2014
Product type
Drugs
Recall number
D-1295-2014
Classification
Class II
Recalling firm
Teva Pharmaceuticals USA
Product quantity
5812 bottles
Termination date
Nov 14, 2014
Reason for recall
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Voluntary / mandated
Voluntary: Firm initiated
Product description
INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
Distribution pattern
Nationwide
Recall initiation date
Mar 24, 2014
Initial firm notification
Letter
Center classification date
May 12, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1295-2014, published May 21, 2014. 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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