Sodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
1,994 FDA recalls mention Chloride. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Chloride.
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Reason Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Reason Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead…
Reason Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Reason Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot..
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Reason Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications…
Reason Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
Reason Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Reason Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Reason Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Reason CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Reason Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.
Reason Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
Reason Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Reason Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
Reason Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination…
Reason Failed Dissolution Test Requirements
Reason Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of…
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