Micro Labs Usa S recalls
Micro Labs Usa S appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2015-03-18.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 6 |
|---|---|
| Published | 2014-11-05 to 2015-03-18 |
| By agency | FDA Drug (6) |
| By classification | Class III (4), Class II (2) |
| By status | terminated (6) |
| Distribution named in notices | CT, FL, MD, MS, NY, US |
Recalls
- Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro…
FDA Drug · Class III · 2015-03-18 · Micro Labs Usa S
Reason: Failed Impurities/Degradation Specifications: Product failed a known impurity specification. - Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro…
FDA Drug · Class III · 2015-03-18 · Micro Labs Usa S
Reason: Failed Impurities/Degradation Specifications: Product failed a known impurity specification. - Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Mic…
FDA Drug · Class III · 2015-03-18 · Micro Labs Usa S
Reason: Failed Impurities/Degradation Specifications: Product failed a known impurity specification. - LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only
FDA Drug · Class II · 2014-11-26 · Micro Labs Usa S
Reason: Failed Content Uniformity Specifications; Dry mix failed blend uniformity. - Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micr…
FDA Drug · Class III · 2014-11-19 · Micro Labs Usa S
Reason: Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification. - GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Mi…
FDA Drug · Class II · 2014-11-05 · Micro Labs Usa S
Reason: Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.