Drug product
Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.
D-0857-2017
Product summary
- Event
- Event 77103
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,200 bottles
- Official record key
drug-enforcement:D-0857-2017
Official wording
Reason: Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Code information: Lot #: JKR5135A, Exp 11/17
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification