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Class II: temporary or reversible health riskTerminated

Major Pharmaceuticals Doxycycline Hyclate Tablets Recall

Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons…

MAJOR PHARMACEUTICALS · Livonia, MI

Risk level
Class II
Reported by FDA
Aug 8, 2018
Recall ID
D-1026-2018
Check your lot numberHow we source this data

Summary

Major Pharmaceuticals recalled Doxycycline Hyclate Tablets starting Jul 30, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1026-2018 on Aug 8, 2018. Reason: Failed Dissolution Specifications. Status: Terminated.

Why it was recalled

Failed Dissolution Specifications

Product description

Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04

Lot numbers, UPCs & expiration codes

Lot: 71545AA, exp 7/2019

Where it was sold

Nationwide USA

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-1026-2018
Classification
Class II
Status
Terminated
Recall initiated
Jul 30, 2018
FDA report date
Aug 8, 2018
Quantity
3,161 Cartons
Recall type
Voluntary: Firm initiated
Recalling firm
MAJOR PHARMACEUTICALS

Original FDA data

Every field from FDA enforcement report D-1026-2018, exactly as published.

Show all FDA fields
City
Livonia
State
MI
Status
Terminated
Country
United States
Event ID
80659
Address
17177 N Laurel Park Dr
Code information
Lot: 71545AA, exp 7/2019
Postal code
48152-2693
Report date
Aug 8, 2018
Product type
Drugs
Recall number
D-1026-2018
Classification
Class II
Recalling firm
MAJOR PHARMACEUTICALS
Product quantity
3,161 Cartons
Termination date
Dec 2, 2019
Reason for recall
Failed Dissolution Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04
Distribution pattern
Nationwide USA
Recall initiation date
Jul 30, 2018
Initial firm notification
Letter
Center classification date
Aug 2, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1026-2018, published Aug 8, 2018. 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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