Class II · Moderate risk
Gastrografin
Presence of foreign substance: One lot of the product may contain black foreign particles
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Merrem I.V.
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Class II · Moderate risk
Estarylla (Norgestimate and Ethinyl Estradiol)
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Class II · Moderate risk
AmBisome (amphotericin B)
Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.
Class II · Moderate risk
AmBisome (amphotericin B)
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
Class II · Moderate risk
Methylphenidate Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Class II · Moderate risk
Methylphenidate Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Class II · Moderate risk
Methylphenidate Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Class II · Moderate risk
Theraflu Cold and Flu
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Exte
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
NeoCitran Extra Strength Non-Drowsy Cold & Sinus
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
NeoCitran DM Cough & Cold
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
NeoCitran Extra Strength Cold & Flu
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
NeoCitran
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
NeoCitran Extra Strength
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Nighttime Severe Cold & Cough
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Flu & Chest Congestion
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Sugar-Free Nighttime Severe Cold & Cough
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu MAX-D Severe Cold & Flu
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Multi-Symptom Severe Cold
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Severe Cold & Cough powder packets containing Daytime formula
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Daytime Severe Cold & Cough
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Flu & Sore Throat
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Belladonna Alkaloids/PB
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.