American Health Packaging Recalls Lisinopril Tablets Due to CGMP Deviations
American Health Packaging is recalling Lisinopril tablets 40mg due to inadequate investigation of customer complaints. The recall covers 1,516 cartons distributed nationwide.
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 indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific deviation is procedural (inadequate complaint investigation) rather than a direct physical contamination or defect, fitting the Moderate severity criteria for minor labeling or process errors without reported illness.
Plain-English summary
American Health Packaging is recalling Lisinopril tablets, USP 40mg, packaged in 10-count blisters. The product is identified by NDC 68084-064-11 for the blisters and NDC 68084-064-01 for the cartons. 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 Current Good Manufacturing Practice (CGMP) deviation. The affected lot number is 131935, with an expiration date of 08/31/2015. A total of 1,516 cartons were distributed nationwide.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. This is a prescription-only medication.
The recalled product
- Product
- Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Affected units
- 1,516
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#: 131935
- Exp 08/31/2015
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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