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Class II: temporary or reversible health riskTerminated

Aidarex Pharmaceuticals Ciprofloxacin 500 mg tablets Recall

Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecut…

Aidarex Pharmaceuticals LLC · Corona, CA

Risk level
Class II
Reported by FDA
Oct 29, 2014
Recall ID
D-0042-2015
Check your lot numberHow we source this data

Summary

Aidarex Pharmaceuticals recalled Ciprofloxacin 500 mg tablets starting May 22, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0042-2015 on Oct 29, 2014. Reason: Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg. Status: Terminated.

Why it was recalled

Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg

Product description

Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India

Lot numbers, UPCs & expiration codes

Lot 39661-3 Exp. 07/15

Where it was sold

Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS

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-0042-2015
Classification
Class II
Status
Terminated
Recall initiated
May 22, 2014
FDA report date
Oct 29, 2014
Quantity
531 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Aidarex Pharmaceuticals LLC

Original FDA data

Every field from FDA enforcement report D-0042-2015, exactly as published.

Show all FDA fields
City
Corona
State
CA
Status
Terminated
Country
United States
Event ID
68375
Address
595 N Smith Ave Ste B
Code information
Lot 39661-3 Exp. 07/15
Postal code
92880-6920
Report date
Oct 29, 2014
Product type
Drugs
Recall number
D-0042-2015
Classification
Class II
Recalling firm
Aidarex Pharmaceuticals LLC
Product quantity
531 bottles
Termination date
Nov 6, 2014
Reason for recall
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Voluntary / mandated
Voluntary: Firm initiated
Product description
Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India
Distribution pattern
Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS
Recall initiation date
May 22, 2014
Initial firm notification
Letter
Center classification date
Oct 23, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0042-2015, published Oct 29, 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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