Why it was recalled
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Product description
Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.
Lot numbers, UPCs & expiration codes
Lot number: DNC0432A, expiration 01/2023
Where it was sold
Nationwide in the USA
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-0361-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 22, 2021
- FDA report date
- Jan 12, 2022
- Quantity
- 696 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0361-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88927
- Address
- 2 Independence Way
- Code information
- Lot number: DNC0432A, expiration 01/2023
- Postal code
- 08540-6620
- Report date
- Jan 12, 2022
- Product type
- Drugs
- Recall number
- D-0361-2022
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 696 Bottles
- Termination date
- Apr 6, 2023
- Reason for recall
- Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 22, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 6, 2022