D-1212-2018 Class III Terminated
FDA drug recall D-1212-2018 was initiated by InvaGen Pharmaceuticals, Inc. on Sep 6, 2018 and is designated Class III. Reason for recall: Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count… The recall status is terminated (terminated Oct 22, 2020). Affected quantity: 26,496 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 26, 2018
- Initiation Date
- Sep 6, 2018
- Termination Date
- Oct 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,496 bottles
Product Description
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
Reason for Recall
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Distribution Pattern
Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide.
Code Information
Lot #: a) 1612130, 1612131, Exp 11/18; 1709986, Exp 8/19; 1711549, Exp 10/19; b) 1701171, 1701174, 1701175, 1701176, Exp 12/18; 1705131, 1705132, 1705133, Exp 4/19; 1709986, 1709985, Exp 8/19; 17110257, Exp 9/19; 1712809, 1801041, 1801051, Exp 12/19; 1802283, Exp 1/20
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1212-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026