Lumberton, NJ, United States
AAA Pharmaceutical, Inc. recalls
3 recalls recorded since 2018, most recently on 14 February 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 14 February 2020
- Terminated
- 5 May 2023
- Reason
- Labeling: Incorrect or Missing Lot and/or Expiration date.
- Distribution
- Ohio
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0868-2020
- Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bo
Terminated Class II Drugs
- Recall started
- 26 December 2019
- Terminated
- 10 March 2021
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Distribution
- Product was distributed to one consignee who may have distributed the product further to their retail stores.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0645-2020, D-0646-2020
- Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
- Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
Terminated Class III Drugs
- Recall started
- 25 June 2019
- Terminated
- 16 December 2020
- Reason
- Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
- Distribution
- KS
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1585-2019
- Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC 8-8397-38781-6 and b) 500 count UPC 8-83967-38786-1 bottles, Distributed by: Kmart Corporation Hoffman Estates, IL 60179
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.