Amlodipine besylate tablets recalled for inadequate complaint investigation
American Health Packaging is recalling Amlodipine besylate tablets 10 mg due to current Good Manufacturing Practice (CGMP) deviations involving 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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The specific deviation is a documentation/investigation failure (CGMP) rather than a direct physical hazard like contamination or mislabeling of a high-risk allergen, fitting the 'Moderate' criteria for minor labeling or documentation issues.
Plain-English summary
American Health Packaging is voluntarily recalling Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters. The recall affects 1,745 cartons of the product, which was distributed nationwide. The specific lot number is 131953, with an expiration date of 07/31/2015.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The product was manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt, USA, LLC in Parsippany, NJ, for American Health Packaging in Columbus, OH.
Consumers and healthcare providers who have this specific lot of Amlodipine besylate tablets should discontinue use and contact their healthcare provider for a replacement or alternative treatment. The recalled product should be returned to the pharmacy or point of purchase.
The recalled product
- Product
- Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); 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
- 1,745
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#: 131953
- 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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