Why it was recalled
Failed Tablet/Capsule Specifications: out of specification for thickness.
Product description
Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA
Lot numbers, UPCs & expiration codes
Lot #s: a) LM10525, Exp 03/15; LM10727, Exp 04/15; LM11519, Exp 08/15; LN10008, Exp 11/15; LN10121, Exp 12/15; LN10887, Exp 04/16; LM11248, Exp 06/16 Lot #s: b) LM10522, Exp 03/15; LM10726, Exp 04/15; LN10007, Exp 11/15; LN10116, Exp 12/15; LN10888, Exp 04/16; LN11281 Exp 07/16
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-0975-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 12, 2015
- FDA report date
- May 13, 2015
- Quantity
- 93,393 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wockhardt Usa Inc.
Original FDA data
Every field from FDA enforcement report D-0975-2015, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 70740
- Address
- 20 Waterview Blvd Ste 3
- Code information
- Lot #s: a) LM10525, Exp 03/15; LM10727, Exp 04/15; LM11519, Exp 08/15; LN10008, Exp 11/15; LN10121, Exp 12/15; LN10887, Exp 04/16; LM11248, Exp 06/16 Lot #s: b) LM10522, Exp 03/15; LM10726, Exp 04/15; LN10007, Exp 11/15; LN10116, Exp 12/15; LN10888, Exp 04/16; LN11281 Exp 07/16
- Postal code
- 07054-1271
- Report date
- May 13, 2015
- Product type
- Drugs
- Recall number
- D-0975-2015
- Classification
- Class II
- Recalling firm
- Wockhardt Usa Inc.
- Product quantity
- 93,393 bottles
- Termination date
- Dec 14, 2017
- Reason for recall
- Failed Tablet/Capsule Specifications: out of specification for thickness.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 12, 2015
- Initial firm notification
- Letter
- Center classification date
- May 1, 2015