The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-66403-002·Announced 2013-11-13

Mylan Recalls Amlodipine and Benazepril Capsules Due to CGMP Deviations

Mylan Pharmaceuticals is recalling specific lots of Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

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 severity score (4) according to the rubric, as it involves a product that could cause temporary or medically reversible adverse health consequences.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling 4,722 bottles of Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles. The affected products are identified by NDC 0378-6895-01 and lot numbers 2003156, 2003157, 2003155, and 3043491.

The recall was initiated because the pharmaceuticals were produced and distributed with active ingredients that were not manufactured according to Good Manufacturing Practices (CGMP Deviations). The FDA has classified this recall as Class II.

The affected products were distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for these specific lot numbers and contact their pharmacist or Mylan Pharmaceuticals for further instructions on how to handle the recalled medication.

The recalled product

Product
Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-6895-01
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
4,722

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 (4)

  • Lot #: 2003156
  • 2003157
  • 2003155
  • 3043491

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 12 recalled by Mylan Pharmaceuticals 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.

See all 12 products in this recall →

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