Why it was recalled
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: STCG005, Exp 01/2015; Lot #: STCG011, Exp 03/2015; Lot #: STCG012, Exp 02/2015.
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0407-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 4, 2014
- FDA report date
- Mar 18, 2015
- Quantity
- 240 (1000-count bottle), 26,904 (90-count bottle)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Micro Labs Usa, Inc S
Original FDA data
Every field from FDA enforcement report D-0407-2015, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 69928
- Address
- 104 Carnegie Ctr
- Address (line 2)
- Te 216
- Code information
- Lot #: STCG005, Exp 01/2015; Lot #: STCG011, Exp 03/2015; Lot #: STCG012, Exp 02/2015.
- Postal code
- 08540-6232
- Report date
- Mar 18, 2015
- Product type
- Drugs
- Recall number
- D-0407-2015
- Classification
- Class III
- Recalling firm
- Micro Labs Usa, Inc S
- Product quantity
- 240 (1000-count bottle), 26,904 (90-count bottle)
- Termination date
- Apr 25, 2018
- Reason for recall
- Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- Dec 4, 2014
- Initial firm notification
- Center classification date
- Mar 11, 2015