Dr. Reddy's Ciprofloxacin Tablets Recalled for Foreign Tablet Contamination
Dr. Reddy's is recalling Ciprofloxacin Tablets due to complaints of mislabeled bottles containing foreign tablets.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 foreign tablets in prescription medication poses a significant risk of harm, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 1,656 bottles of Ciprofloxacin Tablets, USP 500 mg. The recall was initiated after the company received complaints regarding mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets. The specific issue identified for the Ciprofloxacin Tablets is the adulterated presence of foreign tablets.
The affected product is identified by NDC 55111-127-05, Lot C201293, and an expiration date of 08/2013. The product was distributed nationwide and in Puerto Rico.
Consumers should check their medication for this specific lot and expiration date. If they possess the affected product, they should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-127-05
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 1,656
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)
- C201293 Exp Date 08/2013
Distribution
Part of a larger recall action
This product is one of 2 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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