Diphenhydramine HCL Liquid recalled over sterility concerns
- Recall date
- June 24, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- H J Harkins Company Inc dba Pharma Pac recalls Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 5…
- Recall number
- D-1430-2019
- FDA classification
- Class II
- Brand / firm
- H J Harkins Company Inc dba Pharma Pac
- Sold / distributed
- Nationwide Within the United States
Why it was recalled
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
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