The Recall Desk
SevereFDA (Drugs)·D-0042-2015·Announced 2014-10-29

Ciprofloxacin 500 mg Tablets Recalled Due to Foreign Tramadol Tablets

Aidarex Pharmaceuticals is recalling Ciprofloxacin 500 mg tablets because Tramadol 50 mg tablets were found in the bottles.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the presence of a different medication (Tramadol) in a Ciprofloxacin bottle poses a significant risk of serious injury due to incorrect medication administration.

Plain-English summary

Aidarex Pharmaceuticals LLC is recalling Ciprofloxacin 500 mg tablets, 20 count bottles, because foreign Tramadol 50 mg tablets have been found in the product. The affected product is prescription-only and was packaged by Aidarex Pharmaceuticals LLC and manufactured by Unique Pharmaceutical Laboratories in Mumbai, India.

The recall involves 531 bottles with Lot 39661-3 and an expiration date of 07/15. The product was distributed nationwide in the United States, specifically in Florida, South Carolina, Washington, West Virginia, Indiana, Alabama, Virginia, and Mississippi.

Consumers should check their medication for the presence of foreign tablets. If Tramadol 50 mg tablets are found in a bottle of Ciprofloxacin 500 mg, they should stop using the product and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India
Affected units
531

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 39661-3 Exp. 07/15

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically: