Legacy Pharmaceutical Packaging, LLC Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity Found in the Active Pharmaceutical Ingredient (API)
Summary
- Company Announcement Date:
- April 24, 2019
- FDA Publish Date:
- April 27, 2019
- Product Type:
- Drugs
Prescription Drugs - Reason for Announcement:
- Device & Drug Safety, Unapproved Ingredient
- Company Name:
- Legacy Pharmaceutical Packaging
- Brand Name:
- Legacy
- Product Description:
- Losartan Potassium USP
Company Announcement
Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).
NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall.
Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles. The identifying NDC number associated with Legacy’s product is as follows:
Losartan Potassium, USP, 50mg NDC 68645-494-54
The affected Losartan Potassium includes 4 repackaged lots numbers (3 initial repackaged lot and 1 expanded repackaged lot) which are listed below:
| LEGACY NDC# | Name and Strength | Count | Legacy Lot # | Expiry |
|---|---|---|---|---|
| 68645-494-54 | Losartan Potassium Tablets USP 50 mg | 30 | 180190 | 10/2020 |
| 68645-494-54 | Losartan Potassium Tablets USP 50 mg | 30 | 180191 | 10/2020 |
| 68645-494-54 | Losartan Potassium Tablets USP 50 mg | 30 | 181597 | 02/2021 |
| 68645-494-54 | Losartan Potassium Tablets USP 50 mg | 30 | 181598 | 02/2021 |
The product can be identified by checking the product name and repackaged lot number on the bottle containing these products.
Losartan Potassium was distributed by pharmacies nationwide. Legacy Pharmaceutical Packaging LLC is notifying its distributors and customers in writing and is arranging/assisting for return of all recalled products to Inmar Pharmaceutical Services. Instructions for returning recalled products are provided in the recall letter.
Consumers with questions regarding this recall can contact Inmar at 1-877-538-8443, Monday – Friday, 9am – 5pm EST. Consumers should contact their physician or healthcare provider if they have that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- Consumers:
- 1-877-538-8443
No comments:
Post a Comment