Actavis Recalls Gabapentin Capsules Due to Physical Defects
Actavis Elizabeth LLC is recalling specific lots of Gabapentin 400 mg capsules distributed in Puerto Rico due to clumping, breaking, and packaging defects.
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, but the source text describes physical defects (clumping, breaking, packaging issues) without reporting any illnesses, injuries, or deaths, aligning with the 'Moderate' severity criteria for low-risk issues.
Plain-English summary
Actavis Elizabeth LLC is recalling 10,857 bottles of Gabapentin Capsules, USP, 400 mg, distributed in Puerto Rico. The affected products are identified by NDC 14550-513-02 (Lot G01889A2, Exp 06/2015) and NDC 45963-557-50 (Lot G01942A1, Exp 08/2015).
The recall was initiated after Actavis received complaints regarding physical defects in the capsules and packaging. Reported issues include clumping and breaking of capsules, bottles with popped-out bottoms, and creased labels. These defects originated from a single distribution center.
Consumers who possess these specific lots of Gabapentin capsules should stop using them and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- Actavis Elizabeth LLC
- Category
- Drug — Prescription Medication
- Affected units
- 10,857
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 #s: a) G01889A2 Exp 06/2015
- b) G01942A1 Exp 08/2015
UPCs (2)
- 0345963555113
- 0345963556110
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Actavis Elizabeth LLC 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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