The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1466-2016·Announced 2016-08-31

Mylan Amlodipine Tablets Recalled for CGMP Deviations

Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets 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 agency classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural manufacturing deviations that may impact drug efficacy or safety.

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Amlodipine Besylate Tablets, USP, 2.5 mg. The recall involves 100-count unit dose blisters (NDC 51079-450-20) and 30-count tablets per dosage card (NDC 51079-450-63). The affected lots are 3039792, 3037880, 3043938, 3036811, 3037514, 3039975, and 3042583.

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 agency has classified this as a Class II recall.

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 treatment options.

The recalled product

Product
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505…
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 (11)

  • Lot #: a) 3039792
  • Exp 04/14
  • 3037880
  • Exp 01/14
  • 3043938
  • Exp 07/14
  • b) 3036811
  • Exp 10/13
  • 3037514
  • 3039975
  • 3042583

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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