The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1467-2016·Announced 2016-08-31

Mylan Amlodipine Besylate Tablets Recalled for CGMP Deviations

Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets, 5 mg, because they were produced and distributed with active ingredients 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no specific injuries are reported in the text, the deviation from Good Manufacturing Practices for active ingredients in a prescription drug warrants a Severe rating under the Class II criteria.

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Amlodipine Besylate Tablets, USP, 5 mg. The recall involves multiple packaging configurations, including 100-count, 300-count, 25-count, and 30-count cartons, identified by specific NDC codes and lot numbers.

The recall was initiated because the pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices (CGMP Deviations). The affected products were distributed nationwide, as well as in Puerto Rico and Guam.

Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance on alternative treatments or replacements. The specific lot numbers and expiration dates are listed in the structured product information provided by the FDA.

The recalled product

Product
Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d)…
Manufacturer
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Category
Drug — Prescription Medication
Hazard

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 (20)

  • Lot #: a) 3038339
  • Exp 02/14
  • 3043618
  • Exp 06/14
  • b) 3041862
  • Exp 05/14
  • 3044258
  • c) 2120031
  • Exp 01/14
  • 2120067
  • d) 3035787
  • 3035834
  • 3035835
  • Exp 10/13
  • 3037125
  • 3037126
  • 3037127
  • 3037511
  • 3037512
  • 3037513

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 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 3 products in this recall →

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