Class II · Moderate risk Terminated
Macrobid Urinary Tract Anitbacterial
Reason Failed dissolution specifications
Is Pine recalled?
Yes — there is an active recall. 82 ongoing FDA recalls mention Pine (685 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class II · Moderate risk Terminated
Nitrofurantoin Monohydrate/Macrycrystals Capsules
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
C-Atropine Sulf Ophth 0.02%
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
C-Atropine Sulf Ophth 0.01%
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50…
Reason Lack of Processing Controls
Class II · Moderate risk Completed
Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
OCuSOFT Homatropine Hydrobromide Ophthalmic Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
LIDOCAINE 0.75%/Epinephrine 0.025%/BSS 0.56ML SYR
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
EPINEPHrine 1:1000 INJECTION SOLUTION
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
EPINEPHrine 4MG ADDED TO D5W 5%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Atropine Sulfate PF INJ
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Articaine DENTAL
Reason Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.
Class II · Moderate risk Terminated
CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief…
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class I · High risk Terminated
FENTANYL Transdermal System
Reason Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Class II · Moderate risk Terminated
Norepinephrine 16 mg in NS 250 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
NICARdipine 25 mg in NS 250 mL EXCEL bag
Reason Lack of sterility assurance.
Class III · Low risk Terminated
Telmisartan and Amlodipine Tablets 80 mg/5 mg
Reason Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Class II · Moderate risk Terminated
Prostaglandin Quad with Atropine 10:30:1:0.15
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Atropine 0.01% Eye Drops
Reason Lack of sterility assurance.
Class III · Low risk Terminated
Telmisartan and Amlodipine Tablets 80 mg/5 mg
Reason Failed Impurities/Degradation Specifications; 18 month long term stability study.
Class III · Low risk Terminated
Clindamycin Injection
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Clindamycin Injection
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Clindamycin Injection
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.