Class II · Moderate risk
Tramadol Hydrochloride Tablets
Packaging defect: blister packaging inadequately sealed.
Pain Relief & OTC Medication Recalls
Recalls of common over-the-counter and prescription pain relievers.
415 recalls in this category, newest first.
Class II · Moderate risk
Pain Reliever
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Class II · Moderate risk
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk
Gabapentin Tablets
Product mixup: one foreign tablet found in product.
Class II · Moderate risk
Advil Liqui-Gels Solubilized Ibuprofen Capsules
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Advil Ibuprofen Tablets
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Advil Ibuprofen Tablets
CGMP deviation: product outside labeled storage temperature requirements.
Class III · Low risk
Gabapentin Tablets
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Class I · High risk
Advil Liqui Gels
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk
Advil Liqui Gels
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk
Advil (ibuprofen)
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class III · Low risk
NDC 0363-6171-09 Walgreens Sinus Pressure
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class III · Low risk
Acetaminophen 500 mg tablet
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class III · Low risk
Acetaminophen 325 mg tablets
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class II · Moderate risk
Acetaminophen Injection
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
Class III · Low risk
Zynrelef (bupivacaine and meloxicam)
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Class III · Low risk
Aspirin and Extended-Release Dipyridamole Capsules
Failed Tablet/Capsule Specification : Capsule breakage
Class II · Moderate risk
Fw Aspirin Chewable Tablet 36ct Sku 913990 Gs Enteric Aspirin…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Motrin Ib Caplets 24ct Sku999394
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
CORRECTDOSE Children's PAIN RELIEF & Fever Reducer
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Acetaminophen Oral Solution 650 mg / 20.3 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Acetaminophen Oral Solution
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Acetaminophen Oral Solution 160 mg / 5 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
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