The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1262-2015·Announced 2015-07-29

Wockhardt Recalls Zolpidem Tartrate Tablets Due to Complaint Investigation Failures

Wockhardt USA is recalling Zolpidem Tartrate 10 mg tablets because the company did not adequately investigate customer complaints, a violation of current 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 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 falls under the rubric for moderate severity involving procedural or documentation issues without reported immediate physical harm.

Plain-English summary

Wockhardt USA Inc. is recalling Zolpidem Tartrate Tablets, 10 mg, which are prescription-only medications. The affected products are packaged in 100-count bottles (NDC: 64679-715-01) and 500-count bottles (NDC: 64679-715-04). The tablets 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 failed to adequately investigate customer complaints. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected lots include specific expiration dates ranging from April 30, 2015, to December 31, 2015. The total quantity recalled consists of 36,213 bottles of the 100-count packaging and 12,824 bottles of the 500-count packaging. These products were distributed nationwide in the United States, including Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice and contact Wockhardt USA or their healthcare provider for instructions on returning or disposing of the medication.

The recalled product

Product
Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ…
Manufacturer
Wockhardt Usa Inc.
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 (13)

  • A) Lot #: DM11608
  • Expiry: 5/31/2015
  • Lot #: DM11609
  • Lot #: DN10190
  • Expiry: 12/31/2015. B) Lot #: DM11186
  • Expiry: 4/30/2015
  • Lot #: DM11607
  • Lot #: DM13298
  • Expiry: 10/31/2015
  • Lot #: DN10188
  • Expiry: 12/31/2015
  • Lot #: DN10189
  • Expiry: 12/31/2015.

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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