Recalls / Class III
Class IIID-0445-2017
Product
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India
- Brand name
- Bupropion Hydrochloride
- Generic name
- Bupropion Hydrochloride
- Active ingredient
- Bupropion Hydrochloride
- Route
- Oral
- NDCs
- 47335-736, 47335-737, 47335-738
- FDA application
- ANDA078866
- Affected lot / code info
- a) 60 count JKP1184A , exp 2/17; JKP1576A, JKP2517A, JKP2527A, exp 04/17; JKP2768A exp 06/17; KP3895A, JKP4051A, exp 08/17; JKP4052A, JKP4605A exp 09/17 b) 100 count JKP0702A exp 01/17; JKP1186A exp 02/17; JKP2766A, exp 05/17; JKP3368A, JKP3369A exp 06/17; JKP3419A, JKP3420A exp 07/17; JKP4056A, JKP4603A, exp 09/17 c) 500 count JKP0093A, JKP0094A, JKP0703A, JKP0704A, exp 01/17; JKP1182A, JKP1183A, JKP1185A, exp 02/17; JKP1187A, JKP1188A, JKP1577A, JKP1578A, JKP2528A, exp 04/17; JKP2764A, JKP2765A, JKP2767A, exp 05/17; JKP3370A, JKP3371A, exp 06/17; JKP3372A, JKP3417A, JKP3418A, JKP3421A, JKP3889A, exp 07/17; JKP3892A, JKP3893A, JKP3894A, exp 08/17; JKP4053A, JKP4054A, JKP4055A, JKP4057A, JKP4600A, JKP4601A, JKP4602A, exp 09/17; JKP4742A, JKP4743A, exp 10/17
Why it was recalled
Failed Dissolution Specifications; 18 month stability time point
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-12-20
- FDA classified
- 2017-01-25
- Posted by FDA
- 2017-02-01
- Terminated
- 2018-07-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0445-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.