The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1252-2015·Announced 2015-07-29

Wockhardt Recalls Metoprolol Succinate Extended-Release Tablets Due to CGMP Deviations

Wockhardt USA Inc. is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations regarding complaint investigation, which fits the rubric for moderate severity involving procedural or labeling issues without reported serious injury.

Plain-English summary

Wockhardt USA Inc. is recalling specific lots of Metoprolol Succinate Extended-Release Tablets, USP, 200 mg. The affected products are packaged in 100-count and 500-count bottles and are distributed nationwide, including Puerto Rico. The recall involves a total of 34,362 bottles across seven specific lot numbers.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. This is a Class II recall, which indicates a violation of CGMPs or labeling that may cause temporary or medically reversible adverse health consequences.

Consumers with these specific lot numbers should stop using the medication and contact their healthcare provider or pharmacist for guidance. The affected lots are LN10978, LN11007, LN11013, LN11258, LN11259, LN11277, LN11317, and LN11255, all with expiration dates in April or June 2015.

The recalled product

Product
Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview…
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Cardiovascular
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)

  • A) Lot #: LN10978
  • Expiry: 4/30/2015
  • Lot #: LN11007
  • Lot #: LN11013
  • Lot #: LN11258
  • Expiry: 6/30/2015
  • Lot #: LN11259
  • Lot #: LN11277
  • Lot #: LN11317
  • Expiry: 6/30/2015. B) Lot #: LN11255
  • Expiry: 6/30/2015.

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 35 recalled by Wockhardt Usa 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 35 products in this recall →

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