Drug product
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
D-1430-2019
Product summary
- Event
- Event 83195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 bottles
- Official record key
drug-enforcement:D-1430-2019
Official wording
Reason: Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Code information: Lot #: DHI56M, Exp. 12/19
Distribution pattern: Nationwide Within the United States
Derived failure modes
-
Microbial contamination
Microbial Contamination