Dr. Reddy's Recalls Amlodipine and Benazepril Capsules Due to Foreign Tablets
Dr. Reddy's is recalling Amlodipine Besylate and Benazepril Hydrochloride capsules because bottles were mislabeled and contained foreign Ciprofloxacin 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of patients ingesting the wrong medication (Ciprofloxacin instead of Amlodipine/Benazepril).
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 1,656 bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules (5 mg/20 mg). The recall is due to complaints that the bottles were mislabeled and contained foreign Ciprofloxacin tablets.
The affected product is manufactured by Dr. Reddy's Laboratories Limited in India and distributed nationwide and in Puerto Rico. The specific lot number is C201293 with an expiration date of 08/2013.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement medication.
The recalled product
- Product
- AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE)
- Brand
- AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- 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
UPCs (2)
- 0355111339014
- 0355111340010
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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