Amlodipine besylate tablets recalled for inadequate complaint investigation
American Health Packaging is recalling 1,896 cartons of Amlodipine besylate tablets 2.5mg due to inadequate investigation of 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 (inadequate complaint investigation) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
American Health Packaging is recalling 1,896 cartons of Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters. The product is distributed nationwide and is identified by Lot # 131924 with an expiration date of 07/31/2015. The tablets are manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt, USA, LLC in Parsippany, NJ.
The recall was initiated because the firm did not adequately investigate customer complaints, which constitutes a deviation from Current Good Manufacturing Practices (CGMP). The source text does not report any specific illnesses, injuries, or deaths associated with this product.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is classified as FDA Class II.
The recalled product
- Product
- Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA f
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Affected units
- 1,896
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 (2)
- Lot #: 131924
- Exp 07/31/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by American Health Packaging 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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