Drug recall
SOTRET (isotretinoin) Capsules, USP, 40 mg, 30 count per carton (3 x 10 capsule Prescription Packs)…
FDA recall event 53664 · Class III · Ranbaxy, Inc.
Key facts
| Event ID | 53664 |
|---|---|
| Recall numbers | D-036-2010 |
| Recalling firm | Ranbaxy, Inc. |
| Product type | Drugs |
| Products | SOTRET (isotretinoin) Capsules, USP, 40 mg, 30 count per carton (3 x 10 capsule Prescription Packs), Manufactured for: RANBAXY Laboratories Inc., Jacksonville, FL 32257 USA, by: Ranbaxy Laboratories… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products: Out of Specification results for methylparaben and butylated hydroxyanisole (BHA) for one lot of SOTRET (isotretinoin) Capsules, 40 mg. |
| Initiation date | Oct 27, 2009 |
| Termination date | Jan 14, 2010 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3006030168 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports