Food, drugs, devices › Micro Labs Usa, Inc S
Drug recall: Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, M
FDA enforcement event 69928 is a drug recall by Micro Labs Usa, Inc S of Princeton, NJ, initiated 4 Dec 2014 and classified Class III, with 3 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 27% of the 313 drug enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 25 Apr 2018. Initiation: voluntary: firm initiated. Micro Labs Usa, Inc S has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Micro Labs Usa, Inc S, Princeton, NJ.
Reason for recall
"Failed Impurities/Degradation Specifications: Product failed a known impurity specification."
Distribution
"Nationwide."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0407-2015 | Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540 | 240 (1000-count bottle), 26,904 (90-count bottle) | Class III | Terminated | 18 Mar 2015 |
| D-0408-2015 | Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90. | 13488 bottles | Class III | Terminated | 18 Mar 2015 |
| D-0409-2015 | Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90. | 13464 bottles | Class III | Terminated | 18 Mar 2015 |
Context
Other enforcement events for Micro Labs Usa, Inc S
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Oct 2014 | GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, | Drug | Class II | 1 |
| 22 Sep 2014 | LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, I | Drug | Class II | 1 |
| 19 Aug 2014 | Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Man | Drug | Class III | 1 |
All 4 events for Micro Labs Usa, Inc S
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: Product failed a known impurity specification."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 25 Apr 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.