Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Gabapentin Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50
Affected NDC
43547-0333-50
Compare with the code on your package — it is the most precise check available.
Drug: Gabapentin Category: Pain Relief & OTC Medication
- Recalling firm
- Solco Healtcare US LLC
- NDC code
- 43547-0333-50
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0155-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Gabapentin recalls
See all
Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class II · Moderate risk
Gabapentin Tablets 600mg
CGMP Deviations
Other labeling / mix-up recalls from 2017
All labeling / mix-up recalls
Class II · Moderate risk
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe
Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Class III · Low risk
Enoxaparin Sodium
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
Class II · Moderate risk
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg)
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Class II · Moderate risk
7-Keto DHEA 25mg Capsule
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
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