Drug Recall Enforcement Report Class II voluntary initiated by Granules Pharmaceuticals Inc, originally initiated on 07-03-2020 for the product Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India The product was recalled due to cgmp deviations: fda analysis detected n-nitrosodimethylamine (ndma) impurity above the acceptable intake level. The product was distributed nationwide and the recall is currently ongoing.
| Field Name |
Field Value |
| Event ID |
85986 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number |
D-1386-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification |
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern |
US Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description |
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India |
| Reason For Recall |
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level What is the Reason for Recall?
Information describing how the product is defective. |
| Product Quantity |
a) 476,073 bottles; b) 2,100 bottles Product Quantity
The amount of product subject to recall. |
| Voluntary Mandated |
Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date |
07-22-2020 |
| Recall Initiation Date |
07-03-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification |
Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type |
Drugs |
| Recalling Firm |
Granules Pharmaceuticals Inc |
| Code Info |
a) 100 count 4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 4920012A/Jun-22 4920013A/Jul-22 4920014A/Jul-22 4920015A/Aug-22 4920016A/Jan-23 b) 500 count 4920005B/Jun-21 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages |
70010-491-01; 70010-491-05; 70010-491-10; 70010-491-18; 70010-491-19; 70010-491-09; 70010-492-01; 70010-492-05; 70010-492-20; 70010-492-21 |
| Status |
Ongoing |
Recalled Products
