Class II · Moderate risk
Children's Acetaminophen Liquid
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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
DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class III · Low risk
Diclofenac Sodium Topical Solution
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Class II · Moderate risk
Little Remedies New Baby Essentials Kit. Each kit contains 1 each…
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Class II · Moderate risk
Aspirin and Extended-release Dipyridamole Capsules
Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
infants* IBUPROFEN
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk
infants* IBUPROFEN
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk
Children s Advil Suspension Ibuprofen Oral Suspension
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Class III · Low risk
Oxycodone and Acetaminophen Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Labeling: Missing Label
Class II · Moderate risk
RPC APAP Elixir
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
RPC Children's Non-Aspirin
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class II · Moderate risk
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class II · Moderate risk
Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Class III · Low risk
Tramadol Hydrochloride 50 mg tablets
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Tramadol HCl USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Gabapentin USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Diclofenac Sodium USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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