Class II · Moderate risk Terminated
Nimodipine Capsules 30 mg
Reason Crystallization; crystallized nimodipine
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 III · Low risk Terminated
Nicardipine Hydrochloride Injection 25 mg/10 mL
Reason Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Class II · Moderate risk Terminated
Walmart Amlodipine Besylate Tablets
Reason Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg.
Class I · High risk Terminated
Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022…
Reason Non-Sterility
Class II · Moderate risk Terminated
NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%
Reason Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.
Class II · Moderate risk Terminated
Glycerin/Lidocaine/Epinephrine Injection including Glycerin 72%…
Reason Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk Terminated
Oxcarbazepine Oral Suspension
Reason Resuspension Problems: Recalled lot did not meet resuspendability requirements.
Class II · Moderate risk Terminated
Atropine Injection
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class III · Low risk Terminated
Oxcarbazepine Tablets
Reason SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Class III · Low risk Terminated
Select Brand Cough Control CF Max
Reason Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class II · Moderate risk Terminated
Belladonna Alkaloids
Reason Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Class II · Moderate risk Terminated
12-Hour Sinus
Reason Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.
Class II · Moderate risk Terminated
Epinephrine Injection USP
Reason Presence of Particulates; may contain glass particles
Class II · Moderate risk Terminated
QUETIAPINE Fumarate Tablets 25mg 100 Tablets
Reason Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Class II · Moderate risk Terminated
Dr. Reddy's Quetiapine Fumarate Tablets
Reason Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Class II · Moderate risk Terminated
Nimodipine Capsules 30 mg
Reason Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Class II · Moderate risk Terminated
CMS-2374-R4 Custom US Breast Core Biopsy Tray
Reason Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Class II · Moderate risk Terminated
CMS-8934 Custom Phlebectomy Tray
Reason Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Class II · Moderate risk Terminated
Epinephrine **
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk Terminated
Bupivacaine HCL & Epinephrine
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk Terminated
Atropine Sulfate 0.4mg/Ml Injectable 12 Ml
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk Terminated
Pilocarpine HCL P.F in B.S.S Ophthalmic 1% Injectable 36 Ml
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Atropine Ns 3.6mg/0.4mg/0.04mg Injectable 13 Ml
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk Terminated
Mitomycin/Lidocaine/Epinephrine 0.04%/0.02%/0.1% Injectable 5 Ml
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk Terminated
Mepivacaine Hcl/Epinephrine. 2%/1:100
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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