Class II · Moderate risk Ongoing
EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL)…
Reason Lack of Assurance of Sterility
Is Dextran recalled?
13 FDA recalls mention Dextran. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dextran.
Class II · Moderate risk Ongoing
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops…
Reason cGMP deviations and lack of assurance of sterility.
Class I · High risk Ongoing
Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles…
Reason Non-Sterility
Class I · High risk Terminated
Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY…
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class II · Moderate risk Ongoing
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL…
Reason Lack of Assurance of Sterility: Bag has the potential to leak.
Class II · Moderate risk Terminated
INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd…
Reason Failed Stability Specification: out of specification for iron content.
Class II · Moderate risk Terminated
INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC…
Reason Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Class II · Moderate risk Terminated
TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ)…
Reason Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the…
Class III · Low risk Terminated
Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15…
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class II · Moderate risk Terminated
Dextran-70 active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Carboxymethyl Dextran active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic…
Reason Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list…
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