25 FDA recalls mention Gabapentin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Gabapentin.
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Reason Defective container; blister packaging inadequately sealed.
Reason Defective container; blister packaging inadequately sealed.
Reason CGMP Deviations
Reason Cross Contamination
Reason Cross Contamination
Reason Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Reason Product mixup: one foreign tablet found in product.
Reason Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Reason Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Reason Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Reason Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Reason Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Reason Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped…
Reason Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped…
Reason Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Reason Labeling: Label Mixup: GABAPENTIN, Tablet, 600 mg may have potentially been mislabeled as the following drug: ARIPiprazole, Tablet, 15 mg, NDC…
Reason Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.
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