Class II · Moderate risk
Testosterone 100mg Anastrozole 4mg
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone Topical Solution 30mg of testosterone per pump…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective Container; actuator may improperly function and affect dose delivery.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: Cipla USA, Inc., Sunrise, FL 33323 NDC 69097-363-44
Affected NDC
69097-0363-44
Compare with the code on your package — it is the most precise check available.
Drug: Testosterone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Testosterone NDC 69097-0363 |
30 mg/1.5mL | Solution Topical |
Cipla USA Inc. | Rx · CIII |
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- NDC code
- 69097-363-44
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1454-2019 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Testosterone recalls
See all
Class II · Moderate risk
Testosterone 87.5mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 200mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 100mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 75mg
Presence of Foreign substance - potential presence of metal particulate matter
Other recalls by InvaGen Pharmaceuticals, Inc.
All 2019 recalls
Class I · High risk
Vigabatrin for Oral Solution
Defective Container: powder may leak out of the pouch
Class III · Low risk
Gabapentin Tablets USP
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
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