Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries…
Reason Packaging defect: blister packaging inadequately sealed.
Recalls of common over-the-counter and prescription pain relievers.
415 recalls in this category, newest first.
Reason Packaging defect: blister packaging inadequately sealed.
Reason Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Product mixup: one foreign tablet found in product.
Reason CGMP deviation: product outside labeled storage temperature requirements.
Reason CGMP deviation: product outside labeled storage temperature requirements.
Reason CGMP deviation: product outside labeled storage temperature requirements.
Reason CGMP deviation: product outside labeled storage temperature requirements.
Reason Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Reason Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Reason Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Reason Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Reason Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Reason Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Reason Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Reason Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product…
Reason Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Reason Failed Tablet/Capsule Specification : Capsule breakage
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
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