Recalls / Class II
Class IID-0361-2022
Product
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.
- Brand name
- Pregabalin
- Generic name
- Pregabalin
- Active ingredient
- Pregabalin
- Route
- Oral
- NDCs
- 47335-686, 47335-687, 47335-688, 47335-689, 47335-690, 47335-691, 47335-692, 47335-693
- FDA application
- ANDA091157
- Affected lot / code info
- Lot number: DNC0432A, expiration 01/2023
Why it was recalled
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 696 Bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-10-22
- FDA classified
- 2022-01-06
- Posted by FDA
- 2022-01-12
- Terminated
- 2023-04-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0361-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.