Recall: D-1176-2022
Class II - Potentially Harmful
Class IIClassification
2022-06-03Initiated
TerminatedStatus
SUN PHARMACEUTICAL INDUSTRIES Firm
Product
Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
Reason
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Distribution
nationwide.
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.