The Recall Desk
ModerateFDA (Drugs)·D-1271-2015·Announced 2015-07-29

Wockhardt Recalls Metoprolol Succinate Tablets Due to CGMP Deviations

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

What this means for you

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 and involves a CGMP deviation regarding complaint investigation, which fits the criteria for moderate severity involving procedural or labeling issues without reported serious injury.

Plain-English summary

Wockhardt USA Inc. is recalling Metoprolol Succinate Extended-Release Tablets, USP, 50 mg. The affected products are packaged in 100-count bottles, 500-count bottles, 4,000-count pouches for repacking, and 12 x 30 tablet dispenser pack cartons. The tablets are prescription-only and were manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt USA LLC in Parsippany, New Jersey.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The agency has classified this recall as Class II.

The affected products were distributed nationwide in the United States, including Puerto Rico. Specific lot numbers and expiration dates are listed in the source data, with expiration dates ranging from April 30, 2015, to July 31, 2015. Consumers should check their medication for the specific NDC codes and lot numbers listed in the official recall notice and contact their healthcare provider or pharmacist for guidance on replacement medication.

The recalled product

Product
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC:
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 (20)

  • A) Lot #: LN10967
  • Expiry: 4/30/2015
  • Lot #: LN10968
  • Lot #: LN10969
  • Lot #: LN11076
  • Lot #: LN11077
  • Lot #: LN11078
  • Lot #: LN11126
  • Expiry: 5/31/2015
  • Lot #: LN11127
  • Lot #: LN11326
  • Expiry: 6/30/2015
  • Lot #: LN11330
  • Lot #: LN11331
  • Lot #: LN11335
  • Expiry: 7/31/2015. B) Lot #: LN11093
  • Lot #: LN11094
  • Lot #: LN11095
  • Lot #: LN11096
  • Lot #: LN11097

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 →

Related recalls

Same manufacturer · Wockhardt Usa Inc.

See all →

Same hazard · cgmp deviation

See all →