US Drug Recall Register

Is Histamine recalled?

Yes — there is an active recall. 4 ongoing FDA recalls mention Histamine (109 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Histamine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.

Class II · Moderate risk Terminated

Histamine 2.75 mg/mL injectable packaged in an amber glass injectable vial

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0084-2015
Class II · Moderate risk Terminated

Histamine 0.55 mg/mL injectable packaged in an amber glass injectable vial

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0083-2015
Class II · Moderate risk Terminated

Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant

Reason Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.

Ohm Laboratories, Inc. NDC 30142-0724-69 D-1256-2014
Class II · Moderate risk Terminated

Histamine

Reason Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Triangle Compounding D-1069-2013
Class III · Low risk Terminated

Loratadine

Reason Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.

Novartis Consumer Health D-022-2014
Class III · Low risk Terminated

Maximum Strength Comtrex Nighttime Cold & Cough

Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Novartis Consumer Health NDC 0067-2081-24 D-739-2014
Class III · Low risk Terminated

Maximum Strength Comtrex Day/Night Cold & Cough

Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Novartis Consumer Health NDC 0067-2082-32 D-738-2014
Class II · Moderate risk Terminated

ZoDen PD

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 13811-0073-16 D-546-2013
Class II · Moderate risk Terminated

ZoDen DM Drops

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 13811-0080-30 D-545-2013
Class II · Moderate risk Terminated

Trigofen DM Drops

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 13811-0082-30 D-542-2013
Class II · Moderate risk Terminated

Trigofen Drops

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 13811-0081-30 D-541-2013
Class II · Moderate risk Terminated

Tri-Dex PE

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 13811-088-16 D-540-2013
Class II · Moderate risk Terminated

TL-Hist PD Drops

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 13811-083-30 D-539-2013
Class II · Moderate risk Terminated

TL Hist DM

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 13811-068-16 D-538-2013
Class II · Moderate risk Terminated

Mesehist WC

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 13811-0075-16 D-536-2013
Class II · Moderate risk Terminated

Mesehist DM

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 13811-0085-16 D-535-2013
Class II · Moderate risk Terminated

CPM / PSE DM Drops

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 13811-072-30 D-534-2013
Class II · Moderate risk Terminated

CPM / PSE Drops

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 13811-071-30 D-533-2013
Class II · Moderate risk Terminated

Poly Hist Forte

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 50991-210-01 D-529-2013
Class II · Moderate risk Terminated

BroveX PSB DM LIQUID

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 58605-151-01 D-527-2013
Class II · Moderate risk Terminated

BroveX PSB LIQUID

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 58605-150-01 D-526-2013
Class II · Moderate risk Terminated

BroveX PSE DM

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 58605-441-01 D-525-2013
Class II · Moderate risk Terminated

BroveX PSE

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 58605-440-01 D-524-2013
Class II · Moderate risk Terminated

Cardec DM Drops

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 44183-550-30 D-521-2013
Class II · Moderate risk Terminated

Cardec Drops

Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TG United, Inc. NDC 44183-604-30 D-520-2013