Class III · Low risk
Tecfidera (dimethyl fumarate)
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Class III · Low risk
Nystatin Oral Suspension
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class III · Low risk
Nystatin Oral Suspension
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class III · Low risk
Famotidine Injection
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Class III · Low risk
Nabumetone Tablets
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Class III · Low risk
Prednisolone Sodium Phosphate Oral Solution
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Class III · Low risk
Brimonidine Tartrate Opthalmic Solution 0.2%
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class III · Low risk
Brimonidine Tartrate Opthalmic Solution 0.2%
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class III · Low risk
Brimonidine Tartrate Opthalmic Solution 0.2%
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class III · Low risk
Lamotrigine Tablets
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Class III · Low risk
Duavee (conjugated estrogens/bazedoxifene)
Failed Dissolution Specifications
Class III · Low risk
Olanzapine Tablets
Failed Impurities/ Degradation Specifications
Class III · Low risk
Olanzapine Tablets
Failed Impurities/ Degradation Specifications
Class III · Low risk
Clonidine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Class III · Low risk
Lamotrigine Tablets
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Class III · Low risk
Zilretta (triamcinolone acetonide extended-release injectable suspension)
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Class III · Low risk
Gabapentin Tablets USP
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Class III · Low risk
Ethacrynic Acid Tablets USP
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Class III · Low risk
Potassium Acetate Injection
Short Fill
Class III · Low risk
Memantine Hydrochloride Extended-Release Capsules
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Class III · Low risk
Esomeprazole Magnesium Delayed Release Capsules USP
Discoloration: product contains brown pellets
Class III · Low risk
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac)
Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Class III · Low risk
ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Class III · Low risk
ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Class III · Low risk
ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card