Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling 7,584 bottles of Azithromycin 600 mg 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, but the source text cites only a procedural failure (inadequate complaint investigation) without reporting specific injuries, illnesses, or high-risk pathogens, aligning with the 'Moderate' criteria for minor or procedural issues.
Plain-English summary
Wockhardt USA Inc. is recalling 7,584 bottles of Azithromycin Tablets, USP, 600 mg. The product is packaged in 30-count bottles and is available by prescription only. 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 did not adequately investigate customer complaints. The affected lots are LN10991 (expiry 4/30/2015) and LN11381 (expiry 7/31/2015).
The product was distributed nationwide in the United States, including Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-962-01.
- Manufacturer
- Wockhardt Usa Inc.
- Category
- Drug — Antibiotic
- Affected units
- 7,584
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 (4)
- Lot #: LN10991
- Expiry: 4/30/2015
- Lot #: LN11381
- Expiry: 7/31/2015.
Distribution
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.
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